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RecruitingPhase 2NCT07175480

PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

An Open-label, Investigator-initiated, Single Arm, Exploratory Phase 2 Trial Evaluating the Feasibility and Efficiency of PET/CT Directed Free of Therapy Used for Metastatic and Advanced Renal Cell Carcinoma

Sponsor

Jinling Hospital, China

Enrollment

30 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (RCC)Metastatic Renal Cell Carcinoma (mRCC)

Summary

This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria24

  • Male or female subjects aged ≥ 18 years at time of signing informed consent
  • Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
  • Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Karnofsky Performance Status (KPS) grade ≥ 70%
  • Adequate organ and bone marrow function meeting all laboratory criteria:
  • Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
  • Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome)
  • Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula.
  • Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
  • Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment
  • Negative pregnancy status at screening for women of childbearing potential
  • Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy.
  • Patients must achieve complete metabolic response (CMR) or partial metabolic response (PMR) on PET/CT within 24 months of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI.
  • Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Karnofsky Performance Status (KPS) grade ≥ 70%
  • Adequate organ and bone marrow function meeting all laboratory criteria:
  • Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
  • Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome)
  • Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula.
  • Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
  • Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment
  • Negative pregnancy status at screening for women of childbearing potential

Exclusion Criteria38

  • Highly malignant pathology
  • Prior systemic therapy for advanced RCC
  • Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  • ECOG performance status \>1
  • Karnofsky Performance Status (KPS) \<70%
  • Inadequate organ and bone marrow function
  • Bulky or symptomatic disease or hepatic metastases
  • Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment.
  • Concurrent or prior invasive malignancies that could confound efficacy assessment, except adequately treated non-melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix/breast with curative therapy \>3 years ago.
  • Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
  • Uncontrolled comorbidities within 6 months including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections.
  • Major surgery within 4 weeks with unhealed wounds or planned surgery during study
  • Concomitant use of drugs or substances affecting activity or pharmacokinetics of investigational products
  • Hypersensitivity to any component of study drugs
  • Chronic or concurrent immunosuppressive therapy, except Inhaled/topical steroids
  • Medical/psychiatric/social conditions compromising protocol compliance
  • Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
  • Inability to undergo PET/CT or oral drug administration
  • Failure to complete ≥12 months of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or other reasons
  • Failure to achieve CMR or PMR on PET/CT within 24 months after combination therapy; new metastatic lesions or disease progression on PET/CT.
  • Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
  • ECOG performance status \>1
  • Karnofsky Performance Status (KPS) \<70%
  • Inadequate organ and bone marrow function
  • Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
  • Uncontrolled comorbidities including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections.
  • Medical/psychiatric/social conditions compromising protocol compliance
  • Pregnancy, lactation, or refusal of contraception during study period.
  • Inability to undergo PET/CT or oral drug administration
  • Withdrawal Criteria:
  • Disease progression with unsatisfactory efficacy, or occurrence of intercurrent illnesses during treatment or follow-up period.
  • Occurrence of severe treatment-related adverse reactions.
  • Laboratory test results indicating critical safety values.
  • Voluntary withdrawal of informed consent by the patient.
  • Investigator's judgment that withdrawal is in the subject's best interest.
  • Pregnancy during the trial period.
  • Poor patient compliance.
  • Loss to follow-up or death during the trial period.

Interventions

DRUGIntermittent PD-1/PD-L1 ICI + VEGFR-TKI

Any PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.

Locations(1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Nanjing, Jiangsu, China

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NCT07175480

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