Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
CanBas Co. Ltd.
Study ID
NCT04953962
Phase
PHASE2
Status
Completed

Conditions

  • Pancreatic Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC \< 10,000/mm3 at screening.

Key Dates

Start date
Dec 18, 2021
Status verified
Aug 2023
Primary completion
Apr 14, 2023
Completion
Apr 14, 2023

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: CBP501 (25) + Cisplatin + Nivolumab
    CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.
  • Experimental: Arm 2: CBP501 (16) + Cisplatin + Nivolumab
    CBP501 16mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.
  • Experimental: Arm 3: CBP501 (25) + Cisplatin
    CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously.
  • Experimental: Arm 4: Cisplatin + Nivolumab
    Cisplatin 60mg/m2 will be administered as infusion and then Nivolumab 240mg will be administered.

Primary Outcome Measure

Three-month progression free survival rate (3M PFSR) [ Time Frame: 3 months after treatment ]

Locations (20)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC-HOPETucsonArizona85704-
Ochsner Clinic FoundationLos AngelesCalifornia70121-
University of Colorado Cancer CenterAuroraColorado80045-
Medical Oncology Hematology Consultants, PANewarkDelaware19713-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
University of Michigan hospitalAnn ArborMichigan48109-
Minnesota oncology Hematology, P.A.MinneapolisMinnesota55404-
James D SanchezHendersonNevada89052-
Oncology Hematology Care, Inc.CincinnatiOhio45245-
Texas Oncology-Austin MidtownAustinTexas78705-
Mary Crowley Medical Research CenterDallasTexas75230-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Texas Oncology-McAllen South Second StreetMcAllenTexas78503-
Texas Oncology- McKinneyMcKinneyTexas75071-
Texas Oncology-San Antonio NortheastSan AntonioTexas78217-
Baylor Scott & White Medical CenterTempleTexas76508-
Texas Oncology-Northeast TexasTylerTexas75702-
Virginia Cancer Specialists, PCArringtonVirginia22205-
Northwest Medical SpecialtiesTacomaWashington98405-
Northwest Cancer Specialists, P.C.VancouverWashington98684-

Find similar trials in Tucson, AZ

By research site
Arizona Oncology Associates, PC-HOPE· Tucson, AZOchsner Clinic Foundation· Los Angeles, CAUniversity of Colorado Cancer Center· Aurora, COMedical Oncology Hematology Consultants, PA· Newark, DEIllinois Cancer Specialists· Arlington Heights, ILUniversity of Michigan hospital· Ann Arbor, MI

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