Microsatellite Stable (MSS) Colorectal AdenocarcinomasPhase 2NCT03642067
Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer
A Phase 2 study testing Nivolumab and Relatlimab in people with Microsatellite Stable (MSS) Colorectal Adenocarcinomas and Colorectal Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microsatellite Stable (MSS) Colorectal Adenocarcinomas, Colorectal Adenocarcinoma
- What is being tested?
- Nivolumab and Relatlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 18 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ECOG performance status 0 or 1
- Have metastatic or locally advanced microsatellite stable (MSS) colorectal adenocarcinoma.
- Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%.
- Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score < 15%.
- Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required.
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- Must have received at least one chemotherapy regimen.
- Patients with the presence of at least one measurable lesion using RECIST 1.1.
- Patients must have available archival tissue from the surgical resection of their primary tumor.
- Patient's acceptance of tumor biopsies.
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
- Documented LVEF ≥ 50% - 6 month prior to drug administration.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Known history or evidence of brain metastases. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment.
- Require any antineoplastic therapy.
- History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-Lag-3 antibodies.
- Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- Had any cytotoxic drug within 4 weeks prior to initiation of study treatment.
- Hypersensitivity reaction to any monoclonal antibody.
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- Has uncontrolled intercurrent acute or chronic medical illness.
- Has an active known or suspected autoimmune disease.
- Has a diagnosis of immunodeficiency.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- Requires daily supplemental oxygen
- History of interstitial lung disease.
- Requires daily supplemental oxygen.
- Significant heart disease
- History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
- Infection with HIV or hepatitis B or C at screening.
- Has an active infection.
- Unable to have blood drawn.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Woman who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab
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.
- Being tested
- Nivolumab, Relatlimab
- Keywords
- Relatlimab, Nivolumab, Immunotherapy, Anti-PD-1, Anti-LAG-3, Antibody, MSS, PD-L1, Microsatellite stability, Colorectal cancer, Colon cancer, Rectal cancer
- Medical subject headings
- Spinocerebellar Degenerations, Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called OPDIVO, BMS-936558, anti-PD-1
Nivolumab was administered IV on day 1 of each 28 day cycle.
RelatlimabDrug
Also called BMS-986016, anti-LAG-3
Relatlimab was administered IV on day 1 of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer | Experimental | Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area ([%PD-L1 + % acellular mucin]/2) using each participant's primary tumor tissue. A CPM score cutoff of greater than or equal to 15% was used to determine CPM positivity.
Participants received 480mg Nivolumab and 160mg Relatlimab. Receives: Drug: Nivolumab; Drug: Relatlimab |
| Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer | Experimental | Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area ([%PD-L1 + % acellular mucin]/2) using each participant's primary tumor tissue. A CPM score cutoff of less than 15% was used to determine CPM negativity.
Participants received 480mg Nivolumab and 160mg Relatlimab. Receives: Drug: Nivolumab; Drug: Relatlimab |
| Cohort C: Colorectal cancer with no biomarker evaluation required | Experimental | Participants were not pre-screened for composite PD-L1/mucin (CPM) score.
Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg). Receives: Drug: Nivolumab; Drug: Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: 12 months
Secondary outcomes (1)
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Defined using NCI CTCAE v5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start12 Feb 2019
- Primary completion23 Feb 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Microsatellite Stable (MSS) Colorectal AdenocarcinomasStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642067
- Sponsor's protocol ID
- J18119
- Other IDs
- IRB00173537, CA224-068
- Status last verified
- Jun 2025
- First submitted
- 15 Aug 2018
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab
- ClinicalTrials.gov ID
- NCT03642067
- Acronym / sponsor ID
- J18119
- Keywords
- Relatlimab, Nivolumab, Immunotherapy, Anti-PD-1, Anti-LAG-3, Antibody, MSS, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer | Experimental | Drug: Nivolumab, Drug: RelatlimabParticipants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area ([%PD-L1 + % acellular mucin]/2) using each participant's primary tumor tissue. A CPM score cutoff of greater than or equal to 15% was used to determine CPM positivity. Participants received 480mg Nivolumab and 160mg Relatlimab. |
| Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer | Experimental | Drug: Nivolumab, Drug: RelatlimabParticipants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area ([%PD-L1 + % acellular mucin]/2) using each participant's primary tumor tissue. A CPM score cutoff of less than 15% was used to determine CPM negativity. Participants received 480mg Nivolumab and 160mg Relatlimab. |
| Cohort C: Colorectal cancer with no biomarker evaluation required | Experimental | Drug: Nivolumab, Drug: RelatlimabParticipants were not pre-screened for composite PD-L1/mucin (CPM) score. Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years.
- ECOG performance status 0 or 1
- Have metastatic or locally advanced microsatellite stable (MSS) colorectal adenocarcinoma.
- Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%.
- Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score < 15%.
Key exclusion criteria (20 listed)
- Known history or evidence of brain metastases. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment.
- Require any antineoplastic therapy.
- History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-Lag-3 antibodies.
- Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- Had any cytotoxic drug within 4 weeks prior to initiation of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OPDIVO, BMS-936558, anti-PD-1Nivolumab was administered IV on day 1 of each 28 day cycle. | Drug | Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer, Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer, Cohort C: Colorectal cancer with no biomarker evaluation required |
| RelatlimabAlso: BMS-986016, anti-LAG-3Relatlimab was administered IV on day 1 of each 28 day cycle. | Drug | Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer, Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer, Cohort C: Colorectal cancer with no biomarker evaluation required |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
1 secondary outcome
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung Le, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Relatlimab in people with Microsatellite Stable (MSS) Colorectal Adenocarcinomas and Colorectal Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.