Trials Sponsors Conditions Drugs Pricing

Conditions

Oropharyngeal Carcinoma (OPC)

Keywords

Antibody Drug ConjugateNectin-4Oropharyngeal Squamous Cell CarcinomaHPV-veHPV+veHead and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

Objective Response Rate (%)
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Up to 24 months
Overall Survival (months)
Median time to death from any cause
Approximately 3 years from randomization

Secondary Outcomes (10)

Progression Free Survival (Months)
up to 24 months from randomization
Duration of Response (Months)
Up to approximately 2 years
Change in baseline in EORTC QLQ-C30 functional and symptom scales
up to approximately 2 years
Objective Response Rate (%)
Up to approximate 2 years
Time to Response (days)
up to approx 2 years
+5 more secondary outcomes

Study Arms (2)

CRB-701

EXPERIMENTAL

3.6mg/Kg CRB-701 administered intravenously Q3W.

Drug: CRB-701

Investigator's Choice monotherapy

ACTIVE COMPARATOR

Investigator's choice of capecitabine, cetuximab or docetaxel

Drug: capcitabineDrug: Cetuximab (EGFR inhibitor)Drug: Docetaxel

Interventions

CRB-701Drug

CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)

CRB-701

capcitabineDrug

1250 mg/m2 twice daily on days 1-14 of each 21-day cycle

Investigator's Choice monotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.
Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.

Sponsors & Collaborators

Corbus Pharmaceuticals Inc.
Industrylead
CSPC Megalith Biopharmaceutical Co.,Ltd.
Industrycollaborator

Study Sites (111)

Clearview Cancer Institute

Huntsville, Alabama, 38505, United States

NOT_YET_RECRUITING

Clinical Study CoordinatorCONTACT1+ (888)- 374-1015 clinical@corbuspharma.com

MehraCONTACT

Marshall Schreeder, MDPRINCIPAL INVESTIGATOR

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

NOT_YET_RECRUITING

MeSH Terms

Conditions

Oropharyngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabDocetaxel

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinoma, Squamous CellCarcinoma

Study Officials

Cesar Peres, MD
Florida Cancer Specialists and Research Institute and Sarah Cannon Research Institute
PRINCIPAL INVESTIGATOR
Pablo Nenclares, MD
Barts & The London NHS Trust
PRINCIPAL INVESTIGATOR
Ari Rosenberg, MD
University of Chicago
STUDY CHAIR

Central Study Contacts

Clinical Study Coordinator

CONTACT

1+(216) 444-8950 clinical@corbuspharma.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: Sponsor personnel involved in making key trial decisions are masked to efficacy and patient level treatment arm allocation.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 17, 2026

Study Start

September 29, 2026

Actual (reported)

A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

CRB-701

Investigator's Choice monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (111)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

CRB-701

Investigator's Choice monotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (111)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations