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New treatment option for Renal Cell Carcinoma (RCC)
Official title PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
ClinicalTrials.gov ID: NCT07175480
What this study is testing
What is Intermittent PD-1/PD-L1 ICI + VEGFR-TKI?
Intermittent PD-1/PD-L1 ICI + VEGFR-TKI is an investigational medicine, being studied as a potential treatment for renal cell carcinoma (rcc).
Also referred to as Treatment pause.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-screening
- Male or female people 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- Pre-screening
- Male or female people 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...
- 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 Pre-screening
What rules you out
- 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 how well it works assessment, except adequately treated non-melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix/breast with...
- 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...
- 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 Main-screening Inclusion Criteria:
- 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...
- 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 Main-screening Exclusion Criteria:
- 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...
- 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 how well it works, 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.
- Wrong Enrollees: deviation of inclusion or exclusion criteria.
- Poor patient compliance.
- Loss to follow-up or death during the trial period.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.