Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla

NCT05347212 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0684NCI-2022-03632
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the combination of nivolumab and relatlimab can help to control renal medullary carcinoma (RMC) that is locally advanced or metastatic (has spread).

Conditions

Carcinomas; Renal Medullary Carcinoma

Outcome Measures

Primary Outcomes (1)

• To establish the objective response rate (ORR) of patients with locally advanced or metastatic RMC treated with combination nivolumab plus relatlimab.

  through study completion, an average of 2 year

Study Arms (1)

Nivolumab+Relatlimab

EXPERIMENTAL

nivolumab 480 mg IV plus relatlimab 480 mg IV every 4 weeks for up to 2 years

Drug: Nivolumab; Drug: Relatlimab

Interventions

Nivolumab DRUG

Given by IV

Also known as: BMS-936558, Opdivo

Nivolumab+Relatlimab

Relatlimab DRUG

Given by IV

Also known as: BMS-986016

Nivolumab+Relatlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry. Patients with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible.
• Patients will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.
• Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or CT scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
• Patients should be willing to provide a newly obtained fresh core biopsy of a tumor lesion. Not required if there is a recently obtained fresh specimen on an IRB approved correlated trial up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
• Patients can be either naïve for any previous systemic treatment or have had any number of prior systemic therapies. However, patients must not have received prior anticancer therapy with antiPD1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 immune checkpoint inhibitors.
• There must be evidence of progression on or after last treatment regimen received.
• ECOG performance status 0-2
• o NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status.
• Age (at the time of consent/assent): ≥ 18 years
• Consent to MD Anderson companion laboratory protocol 2014-0938
• Within 14 days of the first dose of the study drugs (cycle 1 day 1), patients must have adequate organ and marrow function as defined below:
• Hemoglobina ≥9 g/dl (treatment allowed)
• Absolute neutrophil countb ≥1,000/µL
• Platelets ≥75,000/µL
• total bilirubin ≤ 1.5 mg/dl

You may not qualify if:

• Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• Patients currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapy) within 2 weeks (14 days) prior to study Day 1 are excluded. Patients who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination immunotherapy are eligible.
• Patients with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events or otherwise hinder patient participation in the clinical trial.
• Patients, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that are expected to require major surgery, other than cytoreductive nephrectomy ± retroperitoneal lymph node dissection, during the course of the study.
• Patients who have organ allografts.
• Known or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus or autoimmune vasculitis \[e.g., Wegener's Granulomatosis\] are excluded from this study. Patientswith a history of Hashimoto's thyroiditis only requiring hormone replacement, Type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. If hepatitis C antibody test is positive then active infection has to be confirmed by hepatitis C RNA testing for the patient to be excluded.
• Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting. Patients with active COVID-19 disease as indicated by a positive polymerase reaction (PCR) test are excluded.
• Patients with previous COVID-19 disease are allowed if ≥30 days from last positive test, and COVID-19 symptoms have resolved and/or PCR test is now negative
• Patients must not have received prior anticancer therapy with anti-LAG-3 immune checkpoint inhibitors.
• Patients receiving any concomitant systemic therapy for renal cell cancer are excluded.
• Patients must not be scheduled to receive another experimental drug while on this study.
• Patients who are on high dose steroid (e.g., \> 10mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intra-articular, ocular, or intranasal corticosteroids (with minimal systemic absorption) are allowed. A brief course (\<48 hours) of systemic corticosteroids for prophylaxis (eg, from contrast dye allergy) is permitted.
• Physiological corticosteroid replacement therapy for adrenal insufficiency is also permitted.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma

Interventions

Nivolumab; relatlimab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pavlos Msaouel, MD,PHD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)