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

NCT04398524 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: ISA101b-OPC-03-19
• Study Type: interventional
• Target: 65
• Locations: 9 countries
• Sites: 41

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Oropharynx

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate based on radiographic response

  Measured by RECIST version 1.1.

  20-25 monhts

Study Arms (1)

single arm

EXPERIMENTAL

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

Drug: ISA101b

Interventions

ISA101b DRUG

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

Also known as: Cemiplimab

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ISA Pharmaceuticals: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (41)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University Hospital Antwerp

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Centre Hospitalier Universitaire de Liege

Liège, 4000, Belgium

Location

Clinic of Oncology

Olomouc, Czechia

Location

Institute of Radiation Oncology

Prague, Czechia

Location

University Hospital Motol, Clinic of Oncology

Prague, Czechia

Location

Saint Andre Hospital, Department of Oncology

Bordeaux, 33000, France

Location

Leon Berard Center, Department of Medical Oncology

Lyon, 69008, France

Location

CHU La Timone - La Timone Children's Hospital

Marseille, France

Location

Georges Pompidou European Hospital

Paris, France

Location

Jean Godinot Institute, Cancer Research Center

Reims, France

Location

Paul Strauss Center

Strasbourg, France

Location

Gustave Roussy Institute

Villejuif, France

Location

University Hospital Cologne, Department of Otorhinolaryngology (ENT)

Cologne, 50937, Germany

Location

University Hospital Giessen and Marburg GmbH

Giessen, Germany

Location

University Hospital Mannheim

Mannheim, Germany

Location

Caritas Klinikum

Saarbrücken, Germany

Location

University Hospital Ulm

Ulm, Germany

Location

Hadassah Medical Center

Jerusalem, Israel

Location

The Tel Aviv Sourasky Medical Cente

Tel Aviv, Israel

Location

Università degli Studi di Brescia

Brescia, Italy

Location

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

Milan, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

National Cancer Institute - IRCCS

Naples, Italy

Location

Institute of Cancer Research and Treatment of Candiolo

Turin, 10060, Italy

Location

Hospital Clinic of Barcelona

Barcelona, Spain

Location

University Hospital Vall d'Hebron

Barcelona, Spain

Location

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

L'Hospitalet de Llobregat, 08908, Spain

Location

University Clinic of Navarra - Madrid

Madrid, 28027, Spain

Location

University Clinic of Navarra

Pamplona, 31008, Spain

Location

Guy's Hospital

London, United Kingdom

Location

Royal Marsden Hospital

London, United Kingdom

Location

Royal Marsden Hospital - Sutton

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: July 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

FR (7); GB (3); BE (3); CZ (3); US (8); DE (5); IT (5); IL (2); ES (5)