PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
- Conditions
- Unresectable or Metastatic MelanomaSolid Tumor
- Interventions
- Registration Number
- NCT03993379
- Lead Sponsor
- CytomX Therapeutics
- Brief Summary
To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- At least 18 years of age
- Measurable disease as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Agree to provide tumor tissue and blood samples for biomarker assessment
- Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
- Prior therapy with a chimeric antigen receptor T cell-containing regimen
- History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
- History of myocarditis regardless of the cause
- History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
- History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
- History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CX-072 in combination with anti-cancer therapy-front line CX-072 histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with anti-cancer therapy-Progressed CX-072 histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab CX-072 histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with anti-cancer therapy-Neoadjuvant CX-072 neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Ipilimumab histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
- Primary Outcome Measures
Name Time Method Overall Response Rate by RECIST v 1.1 1 year ORR by RECIST v1.1
- Secondary Outcome Measures
Name Time Method The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST 2 years ORR by irRECIST
The Percentage of Patients Experiencing Treatment Related Adverse Events 2 years Safety and Tolerability of CX-072 in Combination Therapy
Trial Locations
- Locations (27)
Inova Dwight and March Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Beacon Cancer Care
🇺🇸Coeur d'Alene, Idaho, United States
University Medical Center Groningen
🇳🇱Groningen, Netherlands
City of Hope National Medical Center
🇺🇸Duarte, California, United States
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
Multicare Institute for Research and Innovation
🇺🇸Spokane, Washington, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Hospital Clinic de Barcelona. Servicio Oncologia Medica
🇪🇸Barcelona, Spain
Ballarat Oncology and Haematology Services
🇦🇺Wendouree, Victoria, Australia
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hospital Universitario La Paz
🇪🇸Madrid, Spain
START- Madrid
🇪🇸Madrid, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Columbia Medical Center
🇺🇸New York, New York, United States
NYC Cancer Institute
🇺🇸New York, New York, United States
Sunshine Coast University Private Hospital
🇦🇺Sunshine Coast, Queensland, Australia
ICO Hospitalet, Hospital Duran I Reynals
🇪🇸Barcelona, Spain
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
Oregon Health & Science Center
🇺🇸Portland, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States