A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

NCT ID: NCT04398524

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-12-30

Brief Summary

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

Detailed Description

This study will assess the ability of ISA101b plus cemiplimab to improve Overall Response Rate in subjects who have progressed on prior anti-PD-1 therapy.

Conditions

Squamous Cell Carcinoma of the Oropharynx

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months

Group Type: EXPERIMENTAL

ISA101b

Intervention Type: DRUG

ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months

Interventions

ISA101b

ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months

Intervention Type: DRUG

Other Intervention Names

Cemiplimab

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years of age.
• Provide informed consent signed by study patient.
• Willing and able to comply with site visits and study-related procedures and requirements.
• Histologically confirmed recurrent or metastatic HPV16 positive OPC. Patients with squamous cell carcinoma of occult primary site, presenting with lymph node(s) limited only to the neck, are also eligible. Patients should have HPV16 positivity confirmed before being considered a candidate for this study.
• HPV16 genotyping as determined by a specified central reference laboratory. If local specific HPV16 genotype assessment has been performed, the patient can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will then subsequently have to be performed by the central laboratory.
• Patients who have received a minimum total dose of 600 mg of pembrolizumab or 960 mg of nivolumab or equivalent anti-PD-1 antibody with or without chemotherapy for only 1st or 2nd line recurrent/ metastatic HPV16 positive OPC. The last dose of anti-PD-1 must have been no more than 6 months prior to the first dose of study drug. Progressive disease (PD) must have been diagnosed during or after anti-PD-1 therapy (but not longer than 6 months after the last dose), and anti PD-1 therapy (as 1st or 2nd line for recurrent/metastatic HPV16 positive OPC) should have been the last treatment regimen that the patient received before entry into the current trial.
• At least one measurable lesion by CT or MRI per RECIST version 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented disease progression in that site.
• Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria

• Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia and hospital admission) within 4 weeks prior to start of study treatment.
• Patients who, after progressing on anti-PD-1, received additional anti-cancer therapy (chemotherapy, radiotherapy, experimental TKI's, immunotherapy, anti-EGFR antibodies, surgery). The following palliative treatments are allowed:
• palliative radiotherapy (but NOT for target lesions)
• palliative surgery
• bone resorptive therapy such as bisphosphonates and denosumab but only if patients have been on stable doses for > 4 weeks prior to first dose of test treatment
• Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
• Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression.
• Encephalitis, meningitis, organic brain disease (e.g. Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy.
• Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (in the past 5 years). A history of radiation pneumonitis in the radiation field is permitted.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

ISA Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

City of Hope National Medical Center

Duarte, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Anschutz Cancer Pavilion

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

University Hospital Antwerp

Antwerp, , Belgium

University Hospital Ghent

Ghent, , Belgium

Centre Hospitalier Universitaire de Liege

Liège, , Belgium

Clinic of Oncology

Olomouc, , Czechia

Institute of Radiation Oncology

Prague, , Czechia

University Hospital Motol, Clinic of Oncology

Prague, , Czechia

Saint Andre Hospital, Department of Oncology

Bordeaux, , France

Leon Berard Center, Department of Medical Oncology

Lyon, , France

CHU La Timone - La Timone Children's Hospital

Marseille, , France

Georges Pompidou European Hospital

Paris, , France

Jean Godinot Institute, Cancer Research Center

Reims, , France

Paul Strauss Center

Strasbourg, , France

Gustave Roussy Institute

Villejuif, , France

University Hospital Cologne, Department of Otorhinolaryngology (ENT)

Cologne, , Germany

University Hospital Giessen and Marburg GmbH

Giessen, , Germany

University Hospital Mannheim

Mannheim, , Germany

Caritas Klinikum

Saarbrücken, , Germany

University Hospital Ulm

Ulm, , Germany

Hadassah Medical Center

Jerusalem, , Israel

The Tel Aviv Sourasky Medical Cente

Tel Aviv, , Israel

Università degli Studi di Brescia

Brescia, , Italy

European Institute of Oncology (IEO), IRCCS, Department of Otolaryngology and Facial Cervix Surgery

Milan, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

National Cancer Institute - IRCCS

Naples, , Italy

Institute of Cancer Research and Treatment of Candiolo

Turin, , Italy

Hospital Clinic of Barcelona

Barcelona, , Spain

University Hospital Vall d'Hebron

Barcelona, , Spain

Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Oncology

L'Hospitalet de Llobregat, , Spain

University Clinic of Navarra - Madrid

Madrid, , Spain

University Clinic of Navarra

Pamplona, , Spain

Guy's Hospital

London, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Royal Marsden Hospital - Sutton

Sutton, , United Kingdom

Countries

United States; Belgium; Czechia; France; Germany; Israel; Italy; Spain; United Kingdom

Other Identifiers

ISA101b-OPC-03-19

Identifier Type: -

Identifier Source: org_study_id