Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Laryngeal Diseases

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Ramucirumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive ramucirumab IV and pembrolizumab IV every 3 weeks. Cycles are 21 days in length. Treatment will continue until progression or unacceptable toxicity for up to 35 cycles of treatment.

Patients receive pembrolizumab IV every 3 weeks. Cycles are 21 days in length. Treatment will continue until progression or unacceptable toxicity for up to 35 cycles of treatment.

Ramucirumab is administered at a dose of 10 mg/kg over 60 minutes.

Pembrolizumab is administered at a flat dose of 200 mg over 30 minutes.

Douglas R Adkins, M.D.

Peter Oppelt, M.D.

Esther Lu, Ph.D.

This is a phase 2 study investigating the efficacy of ramucirumab in combination with pembrolizumab compared to pembrolizumab monotherapy. Ramucirumab is a VEGFR-2 inhibitor believed to potentially enhance the efficacy of PD-1 inhibitors such as pembrolizumab.

Patients will be randomized on a 2:1 basis to Arm 1 or Arm 2.

Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma

Open-Label, Randomized Phase 2 Trial of Ramucirumab in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-Line Treatment of PD-L1 Positive, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (RM-HNSCC)

ORR is defined as the number of patients with a complete response (CR) and a partial response (PR) by RECIST 1.1 criteria. A CR is defined as the disappearance of all target lesions, reduction in pathological lymph nodes to \<10 mm in short axis, and disappearance of all non-target lesions with normalization of tumor marker level. A PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of overall response is measured from the time criteria are met for a CR or PR per RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Duration of overall CR is measured from the time criteria are met for a CR per RECIST 1.1 until the first date that progressive disease is objectively documented.

PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.

OS is defined as the time from start of treatment to the date of death, censored at the last follow-up otherwise.

AEs will be assessed using CTCAE v4.0 and summarized by arm.

Spots Global Cancer Trial Database for hypopharynx hnscc