Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/10/2018 |
| Start Date: | November 6, 2018 |
| End Date: | October 2022 |
| Contact: | Susan Sartorius-Mergenthaler, RN |
| Email: | Sartosu@jhmi.edu |
| Phone: | 410-614-3644 |
The purpose of this study is to evaluate the safety and clinical activity of nivolumab and
relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory
to prior PD-(L)1 therapy.
relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory
to prior PD-(L)1 therapy.
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
- Have disease progression.
- 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.
- Have received any investigational drugs, a live vaccine, any allergen
hyposensitization therapy, growth factors or major surgery within 28 days prior to
study treatment.
- Hypersensitivity reaction to any monoclonal antibody.
- 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.
- 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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