OncoMatch/Clinical Trials/NCT06029270
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Is NCT06029270 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for metastatic nasopharyngeal carcinoma.
Treatment: Carboplatin · Cisplatin · Gemcitabine · Nivolumab · Relatlimab — This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV, STAGE IV AJCC V8 (AJCC v8)
has recurred locoregionally and/or is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for recurrent/metastatic NPC
Exception: Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence.
No prior systemic treatment of palliative intent for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy.
Cannot have received: PD-1 inhibitor
Exception: except if given as adjuvant or neoadjuvant therapy for NPC
No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC)
Cannot have received: PD-L1 inhibitor
No prior treatment with a PD-L1 inhibitor
Cannot have received: anti-PD-L2 inhibitor
No prior treatment with a PD-L2 inhibitor
Cannot have received: LAG-3 inhibitor
No prior treatment with a LAG-3 inhibitor
Cannot have received: CTLA-4 inhibitor
Exception: except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC
No prior treatment with a CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC)
Cannot have received: T-cell co-stimulation or immune checkpoint pathway inhibitor
No prior treatment with any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Lab requirements
Blood counts
ANC >= 1500 cells/mm^3. Platelets >= 100,000 cells/mm^3. Hemoglobin >= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.)
Kidney function
Serum creatinine <= 1.5 × ULN or calculated creatinine clearance (CrCl) >= 30 mL/min for patients with serum creatinine levels > 1.5 × ULN.
Liver function
Total bilirubin <= 1.5 × ULN or direct bilirubin <= ULN for patients with total bilirubin levels > 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level <= 3 × ULN may be enrolled. ALT <= 3 × ULN (<= 5 × ULN for patients with liver metastases).
Cardiac function
No history of unstable angina requiring hospitalization within the last 6 months. No history of myocardial infarction within the last 6 months. New York Heart Association Functional Classification II or better. Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction < 50% must be stably controlled with medication.
ANC >= 1500 cells/mm^3. Platelets >= 100,000 cells/mm^3. Hemoglobin >= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.). Total bilirubin <= 1.5 × ULN or direct bilirubin <= ULN for patients with total bilirubin levels > 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level <= 3 × ULN may be enrolled. ALT <= 3 × ULN (<= 5 × ULN for patients with liver metastases). Serum creatinine <= 1.5 × ULN or calculated creatinine clearance (CrCl) >= 30 mL/min for patients with serum creatinine levels > 1.5 × ULN. Albumin-adjusted calcium level based on corrected calcium equation <= 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Kaiser Permanente Dublin · Dublin, California
- Kaiser Permanente-Fremont · Fremont, California
- Kaiser Permanente Fresno Orchard Plaza · Fresno, California
- Kaiser Permanente-Fresno · Fresno, California
- Keck Medicine of USC Koreatown · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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