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

Phase 3Not Yet RecruitingNCT07768189

Corbus Pharmaceuticals Inc.260 enrolled

Overview

The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are: * What proportion of participants respond to CRB-701 measured using scans (CT or MRI) * What medical problems do participants experience when taking CRB-701. Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease). Participants will: * Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving. * Have a CT or MRI every 6 weeks to measure the effect on their cancer * Complete questionnaires to assess their health status.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

260

Conditions

Oropharyngeal Carcinoma (OPC)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * ECOG PS of 0-1 * Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation. * Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment. Signed informed consent Exclusion Criteria: * Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia. * Significant active or chronic corneal disorders * Pre-existing Grade ≥2 peripheral neuropathy * Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results. * Pregnant or breastfeeding females

Locations (29)

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of California Los Angeles Westwood Cancer Center

Los Angeles, California, United States

Stanford Medicine - Cancer Center

Palo Alto, California, United States

Moores Cancer Center

San Diego, California, United States

Outcomes

Primary Outcomes

Objective Response Rate (%)

Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)

Time frame: Up to 24 months

Overall Survival (months)

Median time to death from any cause

Time frame: Approximately 3 years from randomization

Secondary Outcomes

Progression Free Survival (Months)

Median time to radiographic progression per RECIST 1.1 as assessed by BICR

Time frame: up to 24 months from randomization

Duration of Response (Months)

Duration of response to intervention as measured by RECIST 1.1 and assessed by BICR

Time frame: Up to approximately 2 years

Change in baseline in EORTC QLQ-C30 functional and symptom scales

Change from baseline in functional and symptom scales on the EORTC QLQ-C30 questionnaire. All individual functions and symptoms are measured on a scale ranging 1-4. In the functional scales a higher score represents better functioning and health. With the symptom scales a higher score represents a more severe symptom and poor health. A total score of 0-100 is derrived from the raw scores with a higher score indicating better health

Time frame: up to approximately 2 years

Objective Response Rate (%)

Proportion of participants that respond to treatment by RECIST 1.1 assessed by Investigator

Time frame: Up to approximate 2 years

Time to Response (days)

Median time to response as measured by RECIST 1.1 and asssessed by BICR

Time frame: up to approx 2 years

Time to Response (days)

Time to response as measured by RECIST v 1.1 as assessed by Investigator

Time frame: up to approximately 2 years

Number of participants experiencing a treatment emergent adverse events

Total number of participant experiencing adverse events per treatment group irrespective of relationship to study treatment.

Time frame: Up to approximately 2 years

Number of participants experiencing a serious treatment emergent adverse event

Number of participants who experienced a serious treatment emergent adverse events per treatment group irrespective of relationship to treatment.

Time frame: Up to approximately 2 years

Number of participants that had a treatment modification due to an adverse event

Number of participants that had a treatment modification due to an adverse event per treatment arm. Dose modifications include dose reductions and treatment delays.

Time frame: Up to approx. 2 years

Number of participants who discontinued study treatment due to a treatment emergent adverse event

Number of participants who discontinued study treatment due to a treatment adverse event per treatment group, irrespective of relationship to the study treatment.

Time frame: Up to approximately 2 years