18 and older, any sex, with Advanced Metastatic Cancer or Advanced Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Benefit Rate (CBR) of Nivolumab With or Without IpilimumabPrimary· Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 months
CBR is defined as the percentage of participants who show clinical benefit, defined as obtaining a complete response (CR; disappearance of all target and non-target lesions), partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), or stable disease (SD) for ≥ 6 months, as determined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
1
"Cold" Tumors for Advanced Metastatic Cancer
18
"Hot" Tumors for Advanced Prostate Cancer
1
"Cold" Tumors for Advanced Prostate Cancer Cohort A
1
"Cold" Tumors for Advanced Prostate Cancer Cohort B
3
Percentage of Participants Whose Tumors Convert From CD8 Low (<15% Tumoral CD8) to CD8 High (>=15%).Primary· From initiation of study intervention through the 2nd on-treatment tumor biopsy, up to 8 months
Percentage of participants in the nivolumab plus ipilimumab ("CD8 low") arm whose tumors convert from CD8 low (\<15%) to CD8 high (\>=15%) as measured by the percentage of tumoral CD8 cells. Participants in the CD8 high arms are not evaluated for this outcome.
On-treatment biopsies for the advanced metastatic cancer cohort were scheduled for as early as possible after the 2nd and 4th doses of ipilimumab (Day 2 - 10 of Cycle 2 and Cycle 6, respectively). On-treatment biopsies for the advanced prostate cancer cohort were scheduled for within 3 days (+/-) of the 2nd and 4th doses of nivolumab (D
Group
Value
95% CI
"Cold" Tumors for Advanced Metastatic Cancer
14
"Cold" Tumors for Advanced Prostate Cancer Cohort A
1
"Cold" Tumors for Advanced Prostate Cancer Cohort B
1
Number of Participants With Treatment-related Adverse Events (TRAE)Secondary· From signing informed consent (prior to Screening) through 100 days after last dose, up to 43 months.
Investigators recorded adverse events (AEs) during each participant encounter. AE severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes.
A TRAE is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, that is deemed 'Possibly', 'Probably'
Any Treatment-related adverse event (TRAE)
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
4
"Cold" Tumors for Advanced Metastatic Cancer
58
"Hot" Tumors for Advanced Prostate Cancer
1
"Cold" Tumors for Advanced Prostate Cancer Cohort A
4
"Cold" Tumors for Advanced Prostate Cancer Cohort B
12
Grade 3 or Grade 4 TRAE
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
0
"Cold" Tumors for Advanced Metastatic Cancer
20
"Hot" Tumors for Advanced Prostate Cancer
0
"Cold" Tumors for Advanced Prostate Cancer Cohort A
2
"Cold" Tumors for Advanced Prostate Cancer Cohort B
6
Grade 5 TRAE
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
0
"Cold" Tumors for Advanced Metastatic Cancer
0
"Hot" Tumors for Advanced Prostate Cancer
0
"Cold" Tumors for Advanced Prostate Cancer Cohort A
0
"Cold" Tumors for Advanced Prostate Cancer Cohort B
0
Serious TRAE
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
0
"Cold" Tumors for Advanced Metastatic Cancer
10
"Hot" Tumors for Advanced Prostate Cancer
0
"Cold" Tumors for Advanced Prostate Cancer Cohort A
1
"Cold" Tumors for Advanced Prostate Cancer Cohort B
6
TRAE leading to treatment discontinuation
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
0
"Cold" Tumors for Advanced Metastatic Cancer
4
"Hot" Tumors for Advanced Prostate Cancer
0
"Cold" Tumors for Advanced Prostate Cancer Cohort A
0
"Cold" Tumors for Advanced Prostate Cancer Cohort B
5
Objective Response Rate (ORR)Secondary· Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 months
Objective Response Rate (ORR) is defined as the percentage of participants who attain a best overall response of complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; \>= 30% decrease in the sum of the longest diameter of target lesions), as determined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
1
"Cold" Tumors for Advanced Metastatic Cancer
14
"Hot" Tumors for Advanced Prostate Cancer
0
"Cold" Tumors for Advanced Prostate Cancer Cohort A
0
"Cold" Tumors for Advanced Prostate Cancer Cohort B
1
Progression-free Survival (PFS)Secondary· Initiation of study drug through death, radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 months
PFS is defined as the time from initiation of study intervention to the date of first documented radiographic progression of disease or date of death due to any cause, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
2.0
1.1 – NA
"Cold" Tumors for Advanced Metastatic Cancer
2.3
2.0 – 4.3
"Hot" Tumors for Advanced Prostate Cancer
NA
NA – NA
"Cold" Tumors for Advanced Prostate Cancer Cohort A
3.7
1.1 – NA
"Cold" Tumors for Advanced Prostate Cancer Cohort B
5.7
2.0 – 7.9
Overall Survival (OS)Secondary· From initiation of study drug until death due to any cause, up to 43 months
OS is defined as the time from initiation of study intervention until death due to any cause. Participants not reported as having died at the time of analysis were censored at the most recent contact date they were known to be alive.
Group
Value
95% CI
"Hot" Tumors for Advanced Metastatic Cancer
15.8
12.1 – NA
"Cold" Tumors for Advanced Metastatic Cancer
13.9
8.9 – 21.1
"Hot" Tumors for Advanced Prostate Cancer
NA
NA – NA
"Cold" Tumors for Advanced Prostate Cancer Cohort A
NA
1.1 – NA
"Cold" Tumors for Advanced Prostate Cancer Cohort B
NA
4.9 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
"Hot" Tumors for Advanced Metastatic Cancer
Serious: 2/7 (29%)
Deaths: 4/7
"Cold" Tumors for Advanced Metastatic Cancer
Serious: 30/72 (42%)
Deaths: 39/72
"Hot" Tumors for Advanced Prostate Cancer
Serious: 0/1 (0%)
Deaths: 0/1
"Cold" Tumors for Advanced Prostate Cancer Cohort A
Serious: 2/5 (40%)
Deaths: 2/5
"Cold" Tumors for Advanced Prostate Cancer Cohort B
Serious: 8/15 (53%)
Deaths: 6/15
Serious adverse events (58 terms)
Reaction
System
"Hot" Tumors for Advanced …
"Cold" Tumors for Advanced…
"Hot" Tumors for Advanced …
"Cold" Tumors for Advanced…
"Cold" Tumors for Advanced…
Pneumonia
Infections and infestations
—
—
—
—
—
Immune-Mediated Enterocolitis
Gastrointestinal disorders
—
—
—
—
—
Thyroiditis
Endocrine disorders
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
Confusional state
Psychiatric disorders
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
Cardio-respiratory arrest
Cardiac disorders
—
—
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
—
—
Hypophysitis
Endocrine disorders
—
—
—
—
—
Retinal vascular disorder
Eye disorders
—
—
—
—
—
Vision blurred
Eye disorders
—
—
—
—
—
Anal incontinence
Gastrointestinal disorders
—
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
Gastritis
Gastrointestinal disorders
—
—
—
—
—
Oesophagitis
Gastrointestinal disorders
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
Influenza like illness
General disorders
—
—
—
—
—
Cholecystitis
Hepatobiliary disorders
—
—
—
—
—
Hypertransaminasaemia
Hepatobiliary disorders
—
—
—
—
—
Hypersensitivity
Immune system disorders
—
—
—
—
—
Peritonitis
Infections and infestations
—
—
—
—
—
Other adverse events (131 terms — click to expand)
This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive nivolumab monotherapy, and participants who have a tumor with \< 15% CD8 cells (classified as CD8 low) will receive ipilimumab in combination with nivolumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Parker Institute for Cancer Immunotherapy
Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03651271.