Clinical Trials /

A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC)

NCT03634540

Description:

An open-label Phase 2 study of belzutifan in combination with cabozantinib in patients with advanced ccRCC.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Trial of PT2977 in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC)
  • Official Title: A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: PT2977-201
  • NCT ID: NCT03634540

Conditions

  • RCC
  • Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • Renal Cancer
  • Renal Cell Carcinoma
  • Renal Cell Cancer Metastatic
  • Renal Cell Carcinoma Recurrent
  • Renal Cell Cancer, Recurrent
  • Kidney

Interventions

DrugSynonymsArms
PT2977 in combination with cabozantinib tabletsPT2977 Tablets, PT-2977, HIF-2α, CabometyxCohort 1: PT2977 and cabozantinib

Purpose

An open-label Phase 2 study of PT2977 in combination with cabozantinib in patients with advanced ccRCC.

Detailed Description

      This is an open-label Phase 2 study which will evaluate the efficacy and safety of PT2977 in
      combination with cabozantinib in patients with advanced ccRCC. PT2977 will be administered
      orally and cabozantinib will be administered orally once daily.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1: PT2977 and cabozantinibExperimentalCohort 1: Patients must not have received prior systemic therapy for advanced or metastatic ccRCC
  • PT2977 in combination with cabozantinib tablets
Cohort 2: PT2977 and cabozantinibExperimentalCohort 2: Patients must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC
  • PT2977 in combination with cabozantinib tablets

Eligibility Criteria

        Inclusion Criteria:

          -  Has the ability to understand and willingness to sign a written informed consent form
             before the performance of any study-specific procedures

          -  18 years of age or older

          -  Has locally advanced or metastatic RCC with predominantly clear cell subtype

          -  Has at least one measurable lesion as defined by RECIST version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Has adequate organ function defined as follows:

               -  Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet
                  count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks
                  prior to obtaining the hematology values at screening;

               -  Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)

               -  Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total
                  bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease

          -  Cohort 1: Patients must not have received prior systemic therapy for advanced or
             metastatic ccRCC

          -  Cohort 2: Patients must have received prior immunotherapy and no more than two prior
             treatments for advanced or metastatic ccRCC

        Exclusion Criteria:

          -  Has received prior treatment with PT2977 or other HIF2α inhibitors

          -  Has received prior treatment with cabozantinib

          -  Has had radiation therapy for bone metastases within two weeks of starting study drug

          -  Has a history of untreated brain metastases or history of leptomeningeal disease or
             spinal cord compression

          -  Has failed to recover from the reversible effects of prior anticancer therapy

          -  Has uncontrolled or poorly controlled hypertension

          -  Is receiving anticoagulant therapy

          -  Has had any major cardiovascular event within 6 months prior to study drug
             administration

          -  Has any other clinically significant cardiac, respiratory, or other medical or
             psychiatric condition that might interfere with participation in the trial or
             interfere with the interpretation of trial results

          -  Has had major surgery within 3 months before first study drug administration

          -  Has an active infection requiring systemic treatment

          -  Is participating in another therapeutic clinical trial
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Approximately 2 Years
Safety Issue:
Description:ORR is defined as the proportion of patients with a best confirmed response of Complete Response (CR) or Partial Response (PR) as determined by the investigator using RECIST 1.1.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Approximately 2 Years
Safety Issue:
Description:PFS is defined as the interval from the start of study treatment until the earlier of the first documentation of disease progression determined by RECIST 1.1 or death from any cause.
Measure:Duration of Response (DOR)
Time Frame:Approximately 2 Years
Safety Issue:
Description:DOR is defined as the interval from the first documentation of response, as determined by RECIST 1.1, to the earlier of the first documentation of disease progression or death from any cause, and calculated for patients with a best confirmed response of CR or PR.
Measure:Time to Response (TTR)
Time Frame:Approximately 2 Years
Safety Issue:
Description:TTR is defined as the interval from the start of study treatment to the first documentation of a response, as determined by RECIST 1.1, and calculated for patients with a best confirmed response of CR or PR.
Measure:Overall Survival (OS)
Time Frame:Approximately 2 Years
Safety Issue:
Description:OS is defined as the interval from the start of treatment to the death of the patient from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Peloton Therapeutics, Inc.

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