Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Tislelizumab

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Participants receive tislelizumab 200 mg intravenously every 3 weeks PLUS lenvatinib 20mg orally once daily.

Yunze Xu, PhD

Qi Lu

FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.

A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC

A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma

ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.

PFS was defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

OS was defined as the time from enrollment to death due to any cause.

DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months.

DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first.

The OS rate was determined for all participants at Month 12 and was defined as the time from enrollment to death due to any cause.

The OS rate was determined for all participants at Month 24 and was defined as the time from enrollment to death due to any cause.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.

RenJi Hospital

Papillary Renal Cell Carcinoma

Chromophil Renal Cell Carcinoma

Chromophobe Renal Cell Carcinoma

Collecting Duct Carcinoma

Dermatologic Agents

Nivolumab

Isotretinoin

Immune Checkpoint Inhibitors

Cohort 1 is designed as a single stage study with a total sample size of 20. This design discriminates between ORR rates of 10 and 35%.

Cohort 2 is designed as a Simon's optimal two-stage design with a total possible sample size of 17. This design discriminates between ORR rates of 5 and 25%.

Cohort 3 is designed as an expansion cohort of Cohort 1 with 20 additional patients to obtain a more precise estimate of the ORR and clinical outcomes

Cohort 4 is an expansion of Cohorts 1+3, which will accure an additional 40 patients

cabozantinib 40mg, self administered orally once daily on a continuous schedule (days 1-28) Patients will continue to take cabozantinib until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.

cabozantinib

Patients will receive an intravenous infusion of nivolumab, per institutional standards, at 240 mg on Cycle 1, Day 1 and will return to the center approximately every two weeks (14 ± 3 days) for subsequent infusions until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.

nivolumab

Darren Feldman, MD

The purpose of this study is to compare any good and bad effects of using a combination of nivolumab (Opdivo®) and cabozantinib (Cabometyx®) in people with metastatic kidney cancer.

This is a single institution open-label phase II trial of cabozantinib and nivolumab in patients with advanced or metastatic non-clear cell Renal Cell Carcinoma (nccRCC), who have not received prior PD-1/PD-L1 directed therapy. This study is designed as separate cohorts defined by histology across three cohorts.

A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma

A Phase 2 Open-Label Study of Nivolumab Combined With Cabozantinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (CA209-9KU)

Memorial Sloan Kettering Cancer Center

Avelumab

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.

Ritesh Kotecha, MD

The purpose of this study is to see whether the combination of avelumab and talazoparib can be an effective treatment for metastatic renal cell carcinoma.

This is a phase II, open-label, single-institution trial.This is a phase II, open-label, single institution clinical trial of combination talazoparib and avelumab in patients with metastatic RCC. This clinical trial will enroll two separate cohorts in parallel.

Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma

Talazoparib and Avelumab in Genomically Defined Metastatic Renal Cell Carcinoma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

confirmed complete response (iCR) or partial response (iPR) assessed by iRECIST.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC	NCT05877820	Fumarate Hydrat...	Tislelizumab Lenvatinib	18 Years - 80 Years	RenJi Hospital
A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma	NCT03635892	Advanced or Met... Unclassified Re... Papillary Renal... Fumarate Hydrat... Succinate Dehyd... Collecting Duct... Chromophobe Ren...	cabozantinib nivolumab	18 Years -	Memorial Sloan Kettering Cancer Center
Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma	NCT04068831	Metastatic Rena... Fumarate Hydrat... Succinate Dehyd...	Talazoparib Avelumab	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma	NCT03635892	Advanced or Met... Unclassified Re... Papillary Renal... Fumarate Hydrat... Succinate Dehyd... Collecting Duct... Chromophobe Ren...	cabozantinib nivolumab	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for fumarate hydratase deficient renal cell carcinoma