CompletedPhase 1/2

Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

United States43 participantsStarted 2019-05-29

Plain-language summary

The investigators hypothesize that inhibition of angiogenesis and PD-1 will be more effective than inhibition of PD-1 alone. The first step in pursuing proof of this hypothesis is to establish the safety and feasibility of combining ramucirumab with pembrolizumab, therefore the first part of this protocol is a de-escalation phase I trial of the combination of ramucirumab + pembrolizumab. The key objective of the phase I trial is to establish the safety and the recommended phase 2 dose (RP2D) of ramucirumab for this novel combination regimen in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM-HNSCC). The second step in pursuing proof of this hypothesis is to establish the efficacy of ramucirumab (using the RP2D) with pembrolizumab. The second part of this protocol is a single arm phase II trial combining ramucirumab + pembrolizumab. The primary objective of the phase II trial is to determine the tumor response rates (complete response (CR) and partial response (PR)) of the treatment combination given as first line therapy in patients with RM-HNSCC.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Incurable HNSCC, defined as RM disease not amenable to cure by surgery and/or radiation therapy or patient with HNSCC declines or is ineligible for curative therapy * In phase I, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, or salivary gland * In phase II, oral cavity, oropharynx, larynx, or hypopharynx * Disease Evaluation: * In phase I, evaluable or measurable disease. * In phase II, measurable disease per RECIST 1.1 * Prior Treatment: * For phase I, any number of lines of prior therapy for RM-HNSCC. * For phase II, no prior systemic therapy for RM-HNSCC. * At least 18 years of age. * Performance status 0-2 (ECOG). * Adequate blood and organ function as defined: * Absolute neutrophil count ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 mg/dL * AST(SGOT) ≤ 3 x institutional upper limit of normal (IULN) and ALT(SGPT) ≤ 3 x IULN. In the setting of liver metastases, AST \< 5 x IULN and ALT \< 5 x IULN. * Creatinine ≤ 2 x ULN OR creatinine clearance ≥ 40 mL/min/1.73 m2 * Urine protein to creatinine ratio (UPC) ≤ 1; if UPC ≥ 1, then a 24-hour urine protein must be assessed; patients must have a 24-hour urine protein value \< 1 g to be eligible * INR ≤ 1.5 x ULN (≤ 3.0 x ULN if on anticoagulation) and PTT ≤ 1.5 x ULN (\<3 x ULN if on anticoagulation) \[Patients are allowed to be on anticoagulation\] * Women of childbearing potential and men must agree to use…

What they're measuring

Recommended phase 2 dose (RP2D) of ramucirumab combined with fixed dose pembrolizumab (Phase I patients only)

Timeframe: Completion of first cycle of treatment for all patients enrolled in Phase I portion of study (estimated to be 2.5 months)

Overall tumor response rate of ramucirumab and pembrolizumab (Phase II patients only)

Timeframe: Through 28 days after completion of treatment (estimated to be 6 months)

Trial details

NCT IDNCT03650764

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

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