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Trial Outcomes & Findings for Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV (NCT NCT04514484)

NCT ID: NCT04514484

Last Updated: 2026-05-28

Results Overview

Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or greater during Cycle 1 due to unresolved toxicity will be considered a DLT.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

28 days

Results posted on

2026-05-28

Participant Flow

Eight participants were registered between November 2021 and January 2024; one did not initiate protocol therapy and is included as a screen failure.

Participant milestones

Participant milestones
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Overall Study
STARTED
7
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Age, Continuous
53 years
n=51 Participants
Sex: Female, Male
Female
0 Participants
n=51 Participants
Sex: Female, Male
Male
7 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=51 Participants
Race (NIH/OMB)
Asian
0 Participants
n=51 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=51 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=51 Participants
Race (NIH/OMB)
White
2 Participants
n=51 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=51 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=51 Participants
Disease Type
Kaposi sarcoma
5 Participants
n=51 Participants
Disease Type
chondrosarcoma
1 Participants
n=51 Participants
Disease Type
metastatic prostate cancer
1 Participants
n=51 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All treated patients

Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or greater during Cycle 1 due to unresolved toxicity will be considered a DLT.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Incidence of Dose Limiting Toxicities (DLTs)
0 patients

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were evaluated for efficacy.

Percentage of participants who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=6 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Objective Response Rate (ORR)
0 percentage of patients
Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients who were evaluated for efficacy.

Percentage of patients who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=6 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Best Overall Response
Stable Disease
83.3 percentage of patients
Interval 35.9 to 99.6
Best Overall Response
Progressive Disease
16.7 percentage of patients
Interval 0.4 to 64.1
Best Overall Response
Complete Response
0 percentage of patients
Interval 0.0 to 45.9
Best Overall Response
Partial Response
0 percentage of patients
Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Up to 24 months

Population: Off treatment patients who were evaluated for efficacy.

Percentage of patients (who are off treatment) who experienced either a Complete Response (CR) or Partial Response (PR) during off treatment period. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=6 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Best Overall Response (Off Treatment)
Complete Response
0 percentage of patients
Interval 0.0 to 45.9
Best Overall Response (Off Treatment)
Partial Response
0 percentage of patients
Interval 0.0 to 45.9
Best Overall Response (Off Treatment)
Stable Disease
83.3 percentage of patients
Interval 35.9 to 99.6
Best Overall Response (Off Treatment)
Progressive Disease
16.7 percentage of patients
Interval 0.4 to 64.1

SECONDARY outcome

Timeframe: At 12 months (from start of treatment)

Population: Treated patients who were evaluated for efficacy.

Percentage of patients without progressive disease at 12 months.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=6 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
12-month Progression-free Survival (PFS)
63 percentage of patients
Interval 14.0 to 89.0

SECONDARY outcome

Timeframe: At 24 months (from start of treatment)

Population: Treated patients who were evaluated for efficacy.

Percentage of patients without progressive disease at 24 months.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=6 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
24-month Progression-free Survival (PFS)
0 percentage of patients
95% CI not determined due to few surviving patients.

SECONDARY outcome

Timeframe: At 12 months

Population: All enrolled patients

Percentage of patients alive at 12 months.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
12-month Overall Survival (OS)
83 percentage of patients
Interval 27.0 to 97.0

SECONDARY outcome

Timeframe: At 24 months

Population: All enrolled patients

Percentage of patients alive at 24 months.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
24-month Overall Survival (OS)
0 percentage of patients
95% CI not determined due to few surviving patients.

SECONDARY outcome

Timeframe: At baseline

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at baseline.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
244 cells/µL
Interval 196.0 to 1123.0

SECONDARY outcome

Timeframe: At Treatment Cycle 1

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 1.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=5 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
289 cells/µL
Interval 179.0 to 1018.0

SECONDARY outcome

Timeframe: At Treatment Cycle 2

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 2.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=3 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
284 cells/µL
Interval 245.0 to 635.0

SECONDARY outcome

Timeframe: At Treatment Cycle 3

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 3.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=2 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
215.5 cells/µL
Interval 162.0 to 269.0

SECONDARY outcome

Timeframe: At Treatment Cycle 4

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 4.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
356 cells/µL
Interval 356.0 to 356.0

SECONDARY outcome

Timeframe: At Treatment Cycle 5

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 5.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
143 cells/µL
Interval 143.0 to 143.0

SECONDARY outcome

Timeframe: At Treatment Cycle 8

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 8.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
115 cells/µL
Interval 115.0 to 115.0

SECONDARY outcome

Timeframe: At Treatment Cycle 11

Population: Treated patients who provided samples for immune function testing.

CD4 immune status at treatment Cycle 11.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD4 Immune Status
64 cells/µL
Interval 64.0 to 64.0

SECONDARY outcome

Timeframe: At baseline

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at baseline.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
775 cells/µL
Interval 269.0 to 1832.0

SECONDARY outcome

Timeframe: At Treatment Cycle 1

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 1.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=5 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
1007 cells/µL
Interval 641.0 to 1544.0

SECONDARY outcome

Timeframe: At Treatment Cycle 2

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 2.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=3 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
887 cells/µL
Interval 788.0 to 1120.0

SECONDARY outcome

Timeframe: At Treatment Cycle 3

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 3.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=2 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
975 cells/µL
Interval 931.0 to 1019.0

SECONDARY outcome

Timeframe: At Treatment Cycle 4

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 4.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
1025 cells/µL
Interval 1025.0 to 1025.0

SECONDARY outcome

Timeframe: At Treatment Cycle 5

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 5.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
1028 cells/µL
Interval 1028.0 to 1028.0

SECONDARY outcome

Timeframe: At Treatment Cycle 8

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 8.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
877 cells/µL
Interval 877.0 to 877.0

SECONDARY outcome

Timeframe: At Treatment Cycle 11

Population: Treated patients who provided samples for immune function testing.

CD8 immune status at treatment Cycle 11.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
CD8 Immune Status
968 cells/µL
Interval 968.0 to 968.0

SECONDARY outcome

Timeframe: At baseline

Population: Treated patients who provided samples for HIV viral load testing.

Human immunodeficiency virus (HIV) viral loads at baseline.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
20 copies/mL
Interval 0.0 to 78.0

SECONDARY outcome

Timeframe: Up to 4 weeks from start of combination treatment

Population: Treated patients who provided samples for HIV viral load testing.

Human immunodeficiency virus (HIV) viral loads at treatment Cycle 1.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=5 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
20 copies/mL
Interval 0.0 to 55.0

SECONDARY outcome

Timeframe: Up to 8 weeks from start of combination treatment

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 2.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=2 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
20 copies/mL
Interval 0.0 to 29.0

SECONDARY outcome

Timeframe: At Treatment Cycle 3

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 3.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=2 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
20 copies/mL
Interval 0.0 to 75.0

SECONDARY outcome

Timeframe: At Treatment Cycle 4

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 4.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
NA copies/mL
The value indicated for HIV is less than 20 (undetectable) - no exact number available

SECONDARY outcome

Timeframe: At Treatment Cycle 5

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 5.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
NA copies/mL
The value indicated for HIV is less than 20 (undetectable) - no exact number available

SECONDARY outcome

Timeframe: At Treatment Cycle 8

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 8.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
NA copies/mL
The value indicated for HIV is less than 20 (undetectable) - no exact number available

SECONDARY outcome

Timeframe: At Treatment Cycle 11

Population: Treated patients who provided samples for HIV viral load testing.

HIV viral loads at treatment Cycle 11.

Outcome measures

Outcome measures
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=1 Participants
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Human Immunodeficiency Virus (HIV) Viral Loads
NA copies/mL
The value indicated for HIV is less than 20 (undetectable) - no exact number available

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 16 weeks post treatment

Change in serum markers of immune activation- immune cell subsets and cytokine levels at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses. Will correlate markers of immune activation and expansion of immune cell subsets and cytokines with clinical outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 16 weeks post treatment

Changes in immune checkpoint (PD-L1, B7x, B7-H3, HHLA2) markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 16 weeks post treatment

Changes in angiogenesis markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 16 weeks post treatment

Changes in infiltrating immune cell markers at each time point from baseline will be analyzed using paired nonparametric Wilcoxon sign-rank tests or paired t-tests in exploratory analyses.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cabozantinib S-malate, Nivolumab)

Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 participants at risk
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Cardiac disorders
Chest pain - cardiac
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Cardiac disorders
Heart failure
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Cardiac disorders
Supraventricular tachycardia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Nausea
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Immune system disorders
Allergic reaction
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Infections and infestations
Cellulitis
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Neutrophil count decreased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Musculoskeletal and connective tissue disorders
Bone pain
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Nervous system disorders
Syncope
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Renal and urinary disorders
Proteinuria
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Renal and urinary disorders
Urinary retention
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Vascular disorders
Thromboembolic event
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.

Other adverse events

Other adverse events
Measure
Treatment (Cabozantinib S-malate, Nivolumab)
n=7 participants at risk
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
Renal and urinary disorders
Glucosuria
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Renal and urinary disorders
Proteinuria
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Nail changes
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify - chronic groin drainage
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Cough
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Dyspnea
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Hoarseness
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Wheezing
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Cardiac disorders
Myocarditis
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Cardiac disorders
Pericardial effusion
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Abdominal pain
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Constipation
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Dysphagia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Gastroesophageal reflux disease
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Gastritis
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Hair color changes
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - diarrhea
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Mucositis oral
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Nausea
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Vomiting
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
General disorders
Gait disturbance
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Activated partial thromboplastin time prolonged
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Alanine aminotransferase increased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Blood lactate dehydrogenase increased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
CD4 lymphocytes decreased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Creatinine increased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Investigations - Other, specify - Aspartate aminotransferase increased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Lymphocyte count decreased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Platelet count decreased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Serum amylase increased
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hyperglycemia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hyperkalemia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hypoglycemia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hyponatremia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Obesity
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Musculoskeletal and connective tissue disorders
Arthralgia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Nervous system disorders
Dizziness
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Nervous system disorders
Dysgeusia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Psychiatric disorders
Anxiety
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Psychiatric disorders
Insomnia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Gastrointestinal disorders
Diarrhea
85.7%
6/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
General disorders
Fatigue
42.9%
3/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Weight loss
42.9%
3/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
White blood cell decreased
42.9%
3/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Anorexia
42.9%
3/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Cardiac disorders
Sinus tachycardia
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Neutrophil count decreased
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Investigations
Thyroid stimulating hormone increased
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hypomagnesemia
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Metabolism and nutrition disorders
Hypophosphatemia
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Respiratory, thoracic and mediastinal disorders
Productive cough
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Vascular disorders
Hypertension
28.6%
2/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Blood and lymphatic system disorders
Anemia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Blood and lymphatic system disorders
Eosinophilia
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Rash maculo-papular
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Erythema of right posterior heel and right toe
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify - Fungal rash
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify - Scalp Rash
14.3%
1/7 • Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 months.

Additional Information

Haiying Cheng, MD - Associate Professor, Department of Oncology

Albert Einstein College of Medicine, Montefiore Einstein Comprehensive Cancer Center

Phone: 718-405-8404

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60