Trial Outcomes & Findings for Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (NCT NCT04126070)
NCT ID: NCT04126070
Last Updated: 2026-05-27
Results Overview
Summarized as percentage with 80% two-sided exact binominal confidence interval (CI) for each cohort
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
7 months from the start of chemoimmunotherapy
Results posted on
2026-05-27
Participant Flow
Due to slow accrual in the biomarker-positive cohorts, enrollment was halted after 47 subjects had been enrolled.
Participant milestones
| Measure |
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
19
|
20
|
|
Overall Study
COMPLETED
|
0
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
16
|
Reasons for withdrawal
| Measure |
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
7
|
|
Overall Study
Progressive disease (clinical or radiographic)
|
2
|
3
|
4
|
|
Overall Study
PSA progression
|
1
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
Baseline Characteristics
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
Baseline characteristics by cohort
| Measure |
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=51 Participants
|
64 years
n=14 Participants
|
67 years
n=65 Participants
|
65 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=51 Participants
|
19 Participants
n=14 Participants
|
20 Participants
n=65 Participants
|
47 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
18 Participants
n=65 Participants
|
41 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
3 Participants
n=24 Participants
|
|
Number of participants with high volume of metastasis
|
6 Participants
n=51 Participants
|
18 Participants
n=14 Participants
|
17 Participants
n=65 Participants
|
41 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 7 months from the start of chemoimmunotherapySummarized as percentage with 80% two-sided exact binominal confidence interval (CI) for each cohort
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy
|
16 percentage of subjects in each cohort
Interval 5.9 to 32.0
|
15 percentage of subjects in each cohort
Interval 5.6 to 30.0
|
38 percentage of subjects in each cohort
Interval 15.0 to 66.0
|
SECONDARY outcome
Timeframe: From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Percentage of Subjects With PSA Less Than or Equal to 0.2 ng/mL During the Chemoimmunotherapy Combination
|
21 percentage of subjects in each cohort
Interval 10.0 to 38.0
|
20 percentage of subjects in each cohort
Interval 9.0 to 36.0
|
50 percentage of subjects in each cohort
Interval 24.0 to 76.0
|
SECONDARY outcome
Timeframe: From the start of chemoimmunotherapy until the end of treatment or initiation of new anti-cancer therapy, whichever occurred first, for a maximum duration of 2 years.Population: Objective response was measured in a subset of population with measurable disease at baseline: 2 in cohort 1, 8 in cohort 2 and 12 in cohort 3. Patients with non-measurable disease at baseline were excluded from this analysis.
Objective response includes "complete response" or "partial response" to the chemoimmunotherapy per RECIST 1.1 criteria.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=12 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=2 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Best Objective Response Rate in Subjects With Measurable Disease Per RECIST 1,1 Criteria
|
4 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from the start of chemoimmunotherapy to death due to any cause, or censored at date last known alive, up to 3-yearsOverall survival rate at 3-years was estimated by the Kaplan-Meier methodology.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Overall Survival Rate at 3-years
|
72 percentage of subjects in each cohort
Interval 46.0 to 87.0
|
59 percentage of subjects in each cohort
Interval 33.0 to 78.0
|
55 percentage of subjects in each cohort
Interval 14.0 to 83.0
|
SECONDARY outcome
Timeframe: Time from the chemoimmunotherapy initiation to date of documented clinical or serological progression with castrate-level testosterone <50 ng/dL, or censored at date of last disease assessment before the start of new anti-cancer therapy, up to 12 monthsCastration resistant disease-free rate at 12 months was estimated from the Kaplan-Meier methodology.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Castration Resistant Disease-free Rate at 12 Months
|
54 percentage of subjects in each cohort
Interval 28.0 to 74.0
|
38 percentage of subjects in each cohort
Interval 16.0 to 60.0
|
47 percentage of subjects in each cohort
Interval 12.0 to 76.0
|
SECONDARY outcome
Timeframe: Time from the chemoimmunotherapy initiation to documented clinical or radiographic progression per RECIST 1.1 criteria, or censored at the date of last disease assessment before the start of new anti-cancer therapy, up to 7 monthsClinical progression free rate at 7 months will be estimated by the Kaplan-Meier methodology.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Clinical Progression Free Rate at 7 Months
|
79 Percentage of subjects in each cohort
Interval 49.0 to 93.0
|
79 Percentage of subjects in each cohort
Interval 47.0 to 93.0
|
80 Percentage of subjects in each cohort
Interval 20.0 to 97.0
|
SECONDARY outcome
Timeframe: Time from the start of chemoimmunotherapy to the date of documented serum PSA progression, or censored at the date of last PSA test before start of new anti-cancer therapy, up to 12 monthsSerum Prostate-Specific Antigen (PSA) progression was defined as ≥50% increase in serum PSA (with a confirmatory increase with PSA above 4 ng/mL. or with starting a new anti-cancer therapy following PSA 50% increase if no confirmatory increase), with the lowest PSA level (nadir) as reference. Serologic progression free rate at 12 months was estimated by the Kaplan-Meier methodology.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
n=19 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
n=20 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=8 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Serologic Progression Free Rate at 12 Months
|
54 percentage of subjects in each cohort
Interval 28.0 to 74.0
|
41 percentage of subjects in each cohort
Interval 17.0 to 64.0
|
47 percentage of subjects in each cohort
Interval 12.0 to 76.0
|
SECONDARY outcome
Timeframe: From the start of chemoimmunotherapy until 6-weeks after the last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 monthsTreatment-related adverse events (TrAEs) included toxicities deemed possibly, probably, or definitely related to nivolumab or docetaxel.
Outcome measures
| Measure |
COHORT 2: Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 3: Biomarker Negative
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
COHORT 1: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor
n=47 Participants
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|---|---|
|
Number (%) of Subjects With Grade 3 or Higher Treatment-related Adverse Events (TrAE) as Assessed by CTCAE v5.0
|
—
|
—
|
28 Participants
|
Adverse Events
Overall Population
Serious events: 20 serious events
Other events: 47 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Overall Population
n=47 participants at risk
Because all three biomarker cohorts received the same protocol-defined treatments, adverse events were reported for the overall population combining all three cohorts, in accordance with the pre-specified analysis plan.
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Myositis
|
4.3%
2/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
2/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Endocrine disorders
Diabetes
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Typhlitis
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Fever
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Hepatobiliary disorders
Immune related hepatitis
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Sepsis
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Skin infection
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
White blood cell decreased
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Impending Fracture
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Myasthenia gravis
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.1%
1/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
Other adverse events
| Measure |
Overall Population
n=47 participants at risk
Because all three biomarker cohorts received the same protocol-defined treatments, adverse events were reported for the overall population combining all three cohorts, in accordance with the pre-specified analysis plan.
All participants received:
* Androgen Deprivation Therapy: Given per standard care for duration of study
* Nivolumab: Given at 360 mg IV per every 3 weeks for cycle 1-6 and then 480 mg IV every 4 weeks during subsequent cycles, for up to 2 years in total duration.
* Docetaxel: Given at 75 mg/m2 IV every 3 weeks for cycle 1-6.
|
|---|---|
|
General disorders and administration site conditions
Fatigue
|
74.5%
35/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Blood and lymphatic system disorders
Anemia
|
46.8%
22/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.8%
22/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Blood lactate dehydrogenase increased
|
42.6%
20/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Diarrhea
|
40.4%
19/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Nausea
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Alanine aminotransferase increased
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Aspartate aminotransferase increased
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Lymphocyte count decreased
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Neutrophil count decreased
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
36.2%
17/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Edema limbs
|
34.0%
16/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Dysgeusia
|
29.8%
14/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.7%
13/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.4%
11/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Creatinine increased
|
19.1%
9/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.4%
11/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Constipation
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Alkaline phosphatase increased
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
21.3%
10/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
19.1%
9/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.1%
9/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.1%
9/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.1%
9/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
17.0%
8/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.0%
8/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Dizziness
|
17.0%
8/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Headache
|
17.0%
8/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
8/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Endocrine disorders
Hyperthyroidism
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Endocrine disorders
Hypothyroidism
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Weight gain
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
White blood cell decreased
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Vascular disorders
Hot flashes
|
14.9%
7/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Pain
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Weight loss
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Psychiatric disorders
Insomnia
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.8%
6/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Platelet count decreased
|
10.6%
5/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.6%
5/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.6%
5/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.6%
5/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
5/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Eye disorders
Watering eyes
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Gastrointestinal disorders
Dry mouth
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Skin infection
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Vascular disorders
Hypertension
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Vascular disorders
Hypotension
|
8.5%
4/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Chills
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Fever
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
General disorders and administration site conditions
Infusion site extravasation
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Lung infection
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Infections and infestations
Upper respiratory infection
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Investigations
Blood bilirubin increased
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Nervous system disorders
Paresthesia
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Psychiatric disorders
Anxiety
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Psychiatric disorders
Depression
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Renal and urinary disorders
Urinary frequency
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
|
|
Vascular disorders
Flushing
|
6.4%
3/47 • From the start of chemoimmunotherapy until 6-weeks after last dose of nivolumab or until resolution or stabilization of the adverse event, up to 31 months
All adverse events (AEs) were graded per the NCI CTCAE v5.0. Per protocol, serious AEs (SAE) included AEs that result in death, life-threatening, impatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, suspected transmission of an infectious agent, or AEs that may jeopardize the subject or require intensive intervention to prevent any serious outcomes listed above. All other non-SAEs were included in "Other Adverse Event" section.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place