18 and older, any sex, with Microsatellite Stable (MSS) Colorectal Adenocarcinomas or Colorectal Adenocarcinoma. 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.
Objective Response Rate (ORR)Primary· 12 months
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Group
Value
95% CI
Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer
0
Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer
1
Cohort C: Colorectal Cancer With no Biomarker Evaluation Required
2
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment DiscontinuationSecondary· 12 months
Defined using NCI CTCAE v5.0
Group
Value
95% CI
Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer
0
Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer
0
Cohort C: Colorectal Cancer With no Biomarker Evaluation Required
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 35 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Composite PD-L1/Mucin (CPM) Positive Colorectal Cancer
Serious: 6/12 (50%)
Deaths: 12/12
Cohort B: Composite PD-L1/Mucin (CPM) Negative Colorectal Cancer
Serious: 12/15 (80%)
Deaths: 15/15
Cohort C: Colorectal Cancer With no Biomarker Evaluation Required
Serious: 11/32 (34%)
Deaths: 26/32
Serious adverse events (30 terms)
Reaction
System
Cohort A: Composite PD-L1/…
Cohort B: Composite PD-L1/…
Cohort C: Colorectal Cance…
Disease progression
General disorders
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Acute kidney injury
Renal and urinary disorders
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Intestinal obstruction
Gastrointestinal disorders
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Urinary tract obstruction
Renal and urinary disorders
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Biliary obstruction
Hepatobiliary disorders
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Pneumonia
Respiratory, thoracic and mediastinal disorders
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Abdominal pain
Gastrointestinal disorders
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Acidosis
Metabolism and nutrition disorders
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Adrenal Insufficiency
Endocrine disorders
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Anemia
Blood and lymphatic system disorders
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Arteriovenous malformation
Vascular disorders
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Ascites
Gastrointestinal disorders
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Cholangitis
Hepatobiliary disorders
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Cholestatic hepatocellular liver injury
Hepatobiliary disorders
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Colitis
Gastrointestinal disorders
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Diabetes mellitus
Metabolism and nutrition disorders
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Diabetic ketoacidosis
Metabolism and nutrition disorders
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Dyspnea
Respiratory, thoracic and mediastinal disorders
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Infection, C. Difficile
Infections and infestations
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Infection, COVID-19
Infections and infestations
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Obstructive hydrocephalus
Nervous system disorders
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Pancreatitis
Gastrointestinal disorders
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Pleural Effusion
Respiratory, thoracic and mediastinal disorders
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Pyelonephritis
Renal and urinary disorders
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Rectal Pain
Gastrointestinal disorders
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Other adverse events (130 terms — click to expand)
The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials
Trials by the same sponsor.
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· recruiting
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 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 15 June 2025
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/NCT03642067.