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CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by CanBas Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
CanBas Co. Ltd.
ClinicalTrials.gov Identifier:
NCT03113188
First received: April 9, 2017
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors
Drug: CBP501
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Dose finding cohort plus confirmatory expansion cohort
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors

Resource links provided by NLM:


Further study details as provided by CanBas Co. Ltd.:

Primary Outcome Measures:
  • Recommended dose [ Time Frame: 21 days ]
    Define the recommended doses (RD) of CBP501, cisplatin and nivolumab when administered in combination once every 21 days in patients with previously treated advanced solid tumors


Estimated Enrollment: 42
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBP501, CDDP, Nivolumab
CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients with Advanced Refractory Tumors
Drug: CBP501
CBP501, CDDP plus Nivolumab

Detailed Description:

This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The study will be conducted in two parts.

The first part of the study involves dose-escalation, in which successive cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached, based on tolerability observed during the first 21 days of treatment.

The second part of the study involves treatment of expansion cohorts of 9 to 12 patients each in specific indications (to be specified by protocol amendment) to confirm the tolerability of treatment at the RD and evaluate evidence of anti-tumor activity in specific indications.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
  2. Previously treated, pathologically confirmed, locally advanced or metastatic solid tumors with measurable disease;
  3. Male or female patients aged ≥ 18 years at time of informed consent;
  4. ECOG Performance Status (PS) 0-1;
  5. Life expectancy > 3 months;
  6. Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, except 8 weeks for bicalutamide);
  7. Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:

    • absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
    • platelet count ≥ 100 x 109/L;
    • hemoglobin ≥ 9 g/dL;
    • white blood cell count (WBC) ≤ upper limit of normal (ULN);
    • creatinine phosphokinase isozymes CPK-MB and CPK-MM

      ≤ ULN;

    • serum troponin T levels within normal limits;
    • bilirubin ≤ 1.5 x ULN;
    • alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present);
    • INR ≤ 1.5 x ULN;
    • creatinine clearance ≥ 60 mL/min (Cockroft & Gault formula);
    • serum potassium NCI-CTCAE version 4.03 Grade <2;
    • serum calcium NCI-CTCAE version 4.03 Grade <2;
    • serum magnesium NCI-CTCAE version 4.03 Grade <2;
  8. Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile";
  9. Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug;
  10. Ability to cooperate with study treatment and follow-up.

Exclusion Criteria:

  1. Radiation therapy to >30% of bone marrow prior to study entry;
  2. Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ≥ 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
  3. Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
  4. Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;
  5. Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance;
  6. Evidence of peripheral neuropathy > grade 1 by NCI-CTCAE version 4.03;
  7. Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry;
  8. Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception;
  9. Known HIV, HBV, or HCV infection;
  10. Active CNS metastases; however, patients with CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03113188

Contacts
Contact: Takumi Kawabe, MDPhD +81559543666 takumi@canbas.co.jp

Sponsors and Collaborators
CanBas Co. Ltd.
Investigators
Principal Investigator: Geoffrey I Shapiro, MD Dana-Farber Cancer Institute
  More Information

Publications:

Responsible Party: CanBas Co. Ltd.
ClinicalTrials.gov Identifier: NCT03113188     History of Changes
Other Study ID Numbers: CBP17-01
Study First Received: April 9, 2017
Last Updated: April 12, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2017