Oropharyngeal Carcinoma (OPC)
Conditions
Keywords
Antibody Drug Conjugate, Nectin-4, Oropharyngeal Squamous Cell Carcinoma, HPV-ve, HPV+ve, Head and Neck Squamous Cell Carcinoma
Brief summary
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.
Interventions
DRUGCRB-701
CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
DRUGcapcitabine
1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
DRUGDocetaxel
75 mg/m2 as an IV infusion on day 1 of each 21-day cycle or 30 mg/m2 weekly to escalate to 40 mg/m2, if tolerated.
Sponsors
Corbus Pharmaceuticals Inc.
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Sponsor personnel involved in making key trial decisions are masked to efficacy and patient level treatment arm allocation.
Intervention model description
Single-blind, multicenter, randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (%) | Up to 24 months | Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR) |
| Overall Survival (months) | Approximately 3 years from randomization | Median time to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (Months) | up to 24 months from randomization | Median time to radiographic progression per RECIST 1.1 as assessed by BICR |
| Duration of Response (Months) | Up to approximately 2 years | Duration of response to intervention as measured by RECIST 1.1 and assessed by BICR |
| Change in baseline in EORTC QLQ-C30 functional and symptom scales | up to approximately 2 years | 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 |
| Objective Response Rate (%) | Up to approximate 2 years | Proportion of participants that respond to treatment by RECIST 1.1 assessed by Investigator |
| Time to Response (days) | up to approx 2 years | Median time to response as measured by RECIST 1.1 and asssessed by BICR |
| Number of participants experiencing a treatment emergent adverse events | Up to approximately 2 years | Total number of participant experiencing adverse events per treatment group irrespective of relationship to study treatment. |
| Number of participants experiencing a serious treatment emergent adverse event | Up to approximately 2 years | Number of participants who experienced a serious treatment emergent adverse events per treatment group irrespective of relationship to treatment. |
| Number of participants that had a treatment modification due to an adverse event | Up to approx. 2 years | Number of participants that had a treatment modification due to an adverse event per treatment arm. Dose modifications include dose reductions and treatment delays. |
| Number of participants who discontinued study treatment due to a treatment emergent adverse event | Up to approximately 2 years | Number of participants who discontinued study treatment due to a treatment adverse event per treatment group, irrespective of relationship to the study treatment. |
Countries
Austria, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORCesar Peres, MD
Florida Cancer Specialists and Research Institute and Sarah Cannon Research Institute
PRINCIPAL_INVESTIGATORPablo Nenclares, MD
Barts & The London NHS Trust
STUDY_CHAIRAri Rosenberg, MD
University of Chicago
Outcome results
None listed