AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllCorbus Pharmaceuticals Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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. *

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2 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
๐Ÿ’Š

What it tests

  • CRB-701
  • capcitabine
  • Cetuximab (EGFR inhibitor)
  • Docetaxel
๐Ÿ“

Where

111 sites
Clearview Cancer Institute
Huntsville, United States
The University of Arizona Cancer Center
Tucson, United States
City of Hope Comprehensive Cancer Center
Duarte, United States
University of California Los Angeles Westwood Cancer Center
Los Angeles, United States
Stanford Medicine - Cancer Center
Palo Alto, United States
Moores Cancer Center
San Diego, United States
UCSF Head and Neck Surgery Cancer Program
San Francisco, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado
Colorado Springs, United States

โ€ฆand 103 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy