Trial Outcomes & Findings for Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab (NCT NCT04401995)
NCT ID: NCT04401995
Last Updated: 2026-07-02
Results Overview
Percentage of patients who experience Pathologic CR (pCR), Partial PR (pPR), or Pathologic NR (pNR) per Immune-related Pathologic Response Criteria. pCR is defined as 0% RVT (residual tumor volume) remaining in post-therapy specimen. pPR is defined a 10%\<%RVT\< 50%. pNR is defined as %RVT\>50%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
At the time of surgery (Week 8-10)
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab
Baseline characteristics by cohort
| Measure |
Total
n=9 Participants
Total of all reporting groups
|
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 9.08 • n=40 Participants
|
69.0 years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
74.8 years
STANDARD_DEVIATION 2.63 • n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=40 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=40 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=40 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: At the time of surgery (Week 8-10)Population: Patients who underwent surgery and were evaluated for pathologic response.
Percentage of patients who experience Pathologic CR (pCR), Partial PR (pPR), or Pathologic NR (pNR) per Immune-related Pathologic Response Criteria. pCR is defined as 0% RVT (residual tumor volume) remaining in post-therapy specimen. pPR is defined a 10%\<%RVT\< 50%. pNR is defined as %RVT\>50%.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Pathologic Response
Pathologic CR
|
75 percentage of patients
Interval 19.4 to 99.4
|
50 percentage of patients
Interval 6.8 to 93.2
|
|
Pathologic Response
Partial PR
|
25 percentage of patients
Interval 0.6 to 80.6
|
25 percentage of patients
Interval 0.6 to 80.6
|
|
Pathologic Response
Pathologic NR
|
0 percentage of patients
Interval 0.0 to 60.2
|
12.5 percentage of patients
Interval 0.6 to 80.6
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Patients evaluated for response to treatment.
The length of time from initiation of treatment until distant-metastasis of melanoma or death.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Distant-metastasis Free Survival (DMFS)
|
NA Days
Median and 95% CI not reached due to insufficient number of events
|
147 Days
Interval 128.0 to
Upper bound of 95% CI not reached due to insufficient number of events
|
PRIMARY outcome
Timeframe: At the time of surgery (Week 8-10)Population: Patients who underwent surgery and were evaluated for pathologic response.
Major Pathologic Response (MPR) is defined as %RVT≤10%.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Major Pathologic Response Rate (MPR)
|
75 percentage of patients
Interval 19.4 to 99.4
|
50 percentage of patients
Interval 6.8 to 93.2
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients evaluated for response to treatment.
The length of time from initiation of treatment until melanoma relapse or death.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Relapse-Free Survival (RFS)
|
NA Days
Median and 95% CI not reached due to insufficient number of events
|
147 Days
Interval 128.0 to
Upper bound of 95% CI not reached due to insufficient number of events
|
SECONDARY outcome
Timeframe: At 6-monthsPopulation: Patients evaluated for response to treatment.
Percentage of patients without disease relapse at 6 months from start of treatment.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
6-month Relapse-Free Survival (RFS)
|
1.000 percentage of patients
Interval 1.0 to 1.0
|
0.333 percentage of patients
Interval 0.067 to 1.0
|
SECONDARY outcome
Timeframe: At 12-monthsPopulation: Patients evaluated for response to treatment.
Percentage of patients without disease relapse at 12 months from start of treatment.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
12-month Relapse-Free Survival (RFS)
|
1.000 percentage of patients
Interval 1.0 to 1.0
|
0.333 percentage of patients
Interval 0.067 to 1.0
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: Patients evaluated for response to treatment.
Percentage of patients without disease relapse at 24 months from start of treatment.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
24-month Relapse-Free Survival (RFS)
|
1.000 percentage of patients
Interval 1.0 to 1.0
|
0.333 percentage of patients
Interval 0.067 to 1.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All trial participants.
The length of (survival) time from the start of treatment until death from any cause.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Days
Median and 95% CI not reached due to insufficient number of events
|
NA Days
Interval 391.0 to
Median and Upper bound of 95% CI not reached due to insufficient number of events
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: All trial participants
Percentage of patients alive at 6 months from the start of treatment until death from any cause.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
6-month Overall Survival (OS)
|
1.00 percentage of patients
Interval 1.0 to 1.0
|
0.75 percentage of patients
Interval 0.426 to 1.0
|
SECONDARY outcome
Timeframe: At 12-monthsPopulation: All trial participants.
Percentage of patients alive at 12 months from the start of treatment until death from any cause.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
12-month Overall Survival (OS)
|
1.00 percentage of patients
Interval 1.0 to 1.0
|
0.75 percentage of patients
Interval 0.426 to 1.0
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: All trial participants.
Percentage of patients alive at 24 months from the start of treatment until death from any cause.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
24-month Overall Survival (OS)
|
1.00 percentage of patients
Interval 1.0 to 1.0
|
0.75 percentage of patients
Interval 0.426 to 1.0
|
SECONDARY outcome
Timeframe: Up to 47 months and 14 daysPopulation: All treated patients.
Toxicities defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 are adverse events classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded and the frequency of toxicities will be tabulated for the study population.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Adverse Events at Least Possibly Related to Study Treatment
Chills
|
4 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Fatigue
|
4 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Fever
|
2 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Neck edema
|
3 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Pain
|
2 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Blood bilirubin increased
|
1 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Blood lactate dehydrogenase increased
|
0 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Blood urea nitrogen increased
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Neutrophil count decreased
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Thyroid stimulating hormone increased
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Hyponatremia
|
3 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Hypophosphatemia
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Arthralgia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Back pain
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Generalized muscle weakness
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Headache
|
2 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Nasal congestion
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Pruritus
|
0 Participants
|
2 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Rash acneiform
|
3 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Rash maculo-papular
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Skin hypopigmentation
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Flushing
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Hypertension
|
2 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Anemia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Adrenal insufficiency
|
0 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Hypothyroidism
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Diarrhea
|
1 Participants
|
1 Participants
|
|
Adverse Events at Least Possibly Related to Study Treatment
Nausea
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVmax -Tumor PET Response Via [18F]F-AraG
|
3.37 g/ml
Standard Deviation 1.10
|
3.27 g/ml
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVpeak -Tumor PET Response Via [18F]F-AraG
|
2.29 g/ml
Standard Deviation 1.04
|
2.69 g/ml
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVmean -Tumor PET Response Via [18F]F-AraG
|
0.905 g/ml
Standard Deviation 0.428
|
0.895 g/ml
Standard Deviation 0.372
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVtotal. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVtotal -Tumor PET Response Via [18F]F-AraG
|
21.7 g/ml
Standard Deviation 11.7
|
40.6 g/ml
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVmax -Tumor PET Response Via [18F]F-AraG
|
2.92 g/ml
Standard Deviation 1.15
|
2.90 g/ml
Standard Deviation 0.311
|
SECONDARY outcome
Timeframe: Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVpeak -Tumor PET Response Via [18F]F-AraG
|
1.64 g/ml
Standard Deviation 0.891
|
1.55 g/ml
Standard Deviation 0.339
|
SECONDARY outcome
Timeframe: Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVmean -Tumor PET Response Via [18F]F-AraG
|
0.761 g/ml
Standard Deviation 0.453
|
0.890 g/ml
Standard Deviation 0.403
|
SECONDARY outcome
Timeframe: Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
SUVtotal -Tumor PET Response Via [18F]F-AraG
|
14.9 g/ml
Standard Deviation 1.82
|
15.7 g/ml
Standard Deviation 0.863
|
SECONDARY outcome
Timeframe: At Baseline and Post Treatment at 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Change in SUVmax -Tumor PET Response Via [18F]F-AraG
|
-0.498 g/ml
Standard Deviation 0.283
|
0.183 g/ml
Standard Deviation 0.462
|
SECONDARY outcome
Timeframe: Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Change in SUVpeak -Tumor PET Response Via [18F]F-AraG
|
-0.822 g/ml
Standard Deviation 0.655
|
-0.215 g/ml
Standard Deviation 0.460
|
SECONDARY outcome
Timeframe: At Baseline and Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=4 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=3 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Change in SUVmean -Tumor PET Response Via [18F]F-AraG
|
-0.170 g/ml
Standard Deviation 0.122
|
0.153 g/ml
Standard Deviation 0.252
|
SECONDARY outcome
Timeframe: At Baseline and Post Treatment - At 5 weeksPopulation: Treated patients who were radiologically evaluable for response.
\[18F\]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVtotal. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.
Outcome measures
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=2 Participants
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
Change in SUVtotal -Tumor PET Response Via [18F]F-AraG
|
-11.2 g/ml
Standard Deviation 10.6
|
-8.91 g/ml
Standard Deviation 15.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment (Screening), at Week 3 of treatment; up to 21 daysThe quantity of CD8 + T-cells that infiltrate tumors, measured via flow cytometry.
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nivolumab With [18F]F-AraG PET/CT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nivolumab and Vidutolimod (CMP-001) Combination With [18F]F-AraG PET/CT
n=5 participants at risk
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2.
Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
Vidutolimod (CMP-001): The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
Nivolumab With [18F]F-AraG PET/CT
n=4 participants at risk
Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3.
Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.
Nivolumab: a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
\[18F\]F-AraG PET/CT: \[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. I\[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
|
|---|---|---|
|
VASCULAR DISORDERS
Flushing
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Leukocytosis
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
CARDIAC DISORDERS
Sinus bradycardia
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
ENDOCRINE DISORDERS
Adrenal insufficiency
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
ENDOCRINE DISORDERS
Hyperthyroidism
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
ENDOCRINE DISORDERS
Hypothyroidism
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
EYE DISORDERS
Eye pain
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Constipation
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
75.0%
3/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Diarrhea
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Dry mouth
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Flatulence
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Nausea
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GASTROINTESTINAL DISORDERS
Stomach pain
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Chills
|
80.0%
4/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Edema face
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Edema limbs
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue
|
80.0%
4/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fever
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
General disorders and administration site conditions - Other, specify Sleep disturbance
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Localized edema
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Neck edema
|
60.0%
3/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Pain
|
80.0%
4/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INFECTIONS AND INFESTATIONS
Eye infection
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INFECTIONS AND INFESTATIONS
Lung infection
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INFECTIONS AND INFESTATIONS
Salivary gland infection
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INFECTIONS AND INFESTATIONS
Urinary tract infection
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INFECTIONS AND INFESTATIONS
Wound infection
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Wound dehiscence
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Alanine aminotransferase increased
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Alkaline phosphatase increased
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Aspartate aminotransferase increased
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Blood bilirubin increased
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Blood lactate dehydrogenase increased
|
60.0%
3/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Creatinine increased
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Hemoglobin increased
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Investigations - Other, specify Blood urea nitrogen increased
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Investigations - Other, specify Prothrombin Time prolonged
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Lymphocyte count decreased
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Neutrophil count decreased
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
Thyroid stimulating hormone increased
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
INVESTIGATIONS
White blood cell decreased
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Anorexia
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperglycemia
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperkalemia
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hypermagnesemia
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hyperuricemia
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hypokalemia
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hypomagnesemia
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hyponatremia
|
60.0%
3/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
METABOLISM AND NUTRITION DISORDERS
Hypophosphatemia
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Back pain
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Generalized muscle weakness
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Pain in extremity
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
NERVOUS SYSTEM DISORDERS
Dizziness
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
NERVOUS SYSTEM DISORDERS
Facial muscle weakness
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
NERVOUS SYSTEM DISORDERS
Headache
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
NERVOUS SYSTEM DISORDERS
Nervous system disorders - Other, specify Peripheral sensory neuropathy
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RENAL AND URINARY DISORDERS
Dysuria
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RENAL AND URINARY DISORDERS
Proteinuria
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Nasal congestion
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Pneumonitis
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Productive cough
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Sore throat
|
20.0%
1/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Pruritus
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
50.0%
2/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash acneiform
|
60.0%
3/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash maculo-papular
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin hypopigmentation
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Skin ulceration
|
0.00%
0/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
25.0%
1/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
|
VASCULAR DISORDERS
Hypertension
|
40.0%
2/5 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
0.00%
0/4 • Adverse Events data were collected for up to 13 months. All-Cause Mortality data was collected for up to 47 months and 14 days.
Adverse Events and Serious Adverse Events were collected per CTCAE v 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place