New drug duo takes on Treatment-Resistant cancers
NCT ID NCT03607890
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether combining two immunotherapy drugs, nivolumab and relatlimab, can shrink or control advanced solid tumors with a specific genetic feature (MSI-H) that have stopped responding to prior immunotherapy. About 38 adults with these hard-to-treat cancers will receive the drug combination every 28 days for up to 2 years. The study aims to see how many patients respond and to track any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and relatlimab (immunotherapy drugs)
- What this could lead to
- If it works, this could offer a new treatment option for people with certain hard-to-treat cancers that no longer respond to standard immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 38 participants, so results may not apply to everyone. The drugs can cause immune-related side effects, and the cancer may still progress.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
38 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have metastatic or locally advanced mismatch repair deficient/MSI-H disease. * Patients must have received prior PD-1/PD-L1 inhibitor therapy * Patients with the presence of at least one measurable lesion. * Life expectancy of greater than 3 months. * Patients must have adequate organ and marrow function defined by study - specified laboratory tests. * Documented left ventricular ejection fraction (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. Exclusion Criteria: * Known history or evidence of brain metastases. * Require any antineoplastic therapy. * History of prior treatment with anti-LAG3. * Had chemotherapy, radiation, or steroids within 14 days prior to study treatment. * Had any investigational cytotoxic drug within 4 weeks prior to study treatment. * Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment. * Major surgery * Hypersensitivity reaction to any monoclonal antibody. * 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. * 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. * Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4 * Woman who are pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
-
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States