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OncoMatch/Clinical Trials/NCT06771544

Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma

Is NCT06771544 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Cyclophosphamide for melanoma.

Phase 2RecruitingUniversity of California, IrvineNCT06771544Data as of Jun 2026

Treatment: Pembrolizumab · CyclophosphamideThis is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Chemotherapy

Cyclophosphamide

Cancer type

Melanoma

Biomarker criteria

Allowed: BRAF driver mutation

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-PD-1 therapy

Has progressed on a prior PD-1/PD-L1 treatment

Cannot have received: BRAF inhibitor

Exception: allowed if patient declines or is unable to tolerate BRAF and/or MEK inhibitors

Presence of B-RAF driver mutation without prior receipt of BRAF +/- MEK inhibitors, unless patient declines BRAF +/-MEK inhibition for any reason or is unable to tolerate BRAF and/or MEK inhibitors.

Cannot have received: allogeneic tissue/solid organ transplant

Participants with a history of allogeneic tissue/solid organ transplant

Cannot have received: any prior investigational or standard cancer therapy (except PD-1/PD-L1, chemotherapy or radiation within 6-9 weeks of first dose)

Exception: PD-1/PD-L1, chemotherapy, or radiation allowed if outside 6-9 week window

Any prior investigational or standard cancer therapy, with exception of PD-1/PD-L1 (includes nivolumab + Relatlimab) therapy, chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy

Lab requirements

Blood counts

Hemoglobin ≥9.0 g/dL; Platelets ≥100/mm3; ANC ≥1.5/mm3; Albumin < 3.0 g/dL is exclusionary; Absolute lymphocyte count < 0.5 × 10^9/L is exclusionary

Kidney function

Creatinine Clearance ≥ 30mL/min Cockcroft-Gault; Glomerular filtration rate < 30 mL/min is exclusionary

Liver function

AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin < 3.1 mg/dL.

Adequate bone marrow, liver, and renal function; Hemoglobin ≥9.0 g/dL; Platelets ≥100/mm3; ANC ≥1.5/mm3; Creatinine Clearance ≥ 30mL/min Cockcroft-Gault; AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin < 3.1 mg/dL.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Chao Family Comprehensive Cancer Center University of California, Irvine · Orange, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06771544 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BRAF inhibitor, allogeneic tissue/solid organ transplant, any prior investigational or standard cancer therapy (except PD-1/PD-L1, chemotherapy or radiation within 6-9 weeks of first dose) disqualifies patients from enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Melanoma trials