RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Sasanlimab for Advanced Clear Cell Renal Carcinoma (Ccrcc)

Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments.

Official registry: https://clinicaltrials.gov/study/NCT05665361 · National Cancer Institute (NCI) · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sasanlimab, or Palbocicilib. The registry lists allocation as randomized. Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States.

They plan to enroll about 100 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)

Interventions: Sasanlimab, Palbocicilib

Primary outcome (registry wording): Phase I: To determine RP2D of palbociclib in combination with sasanlimab

Who it is for (from inclusion criteria)

Ages 18 Years to 100 Years
Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)
Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1
Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)
Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC
how well you can do daily activities (ECOG score) \<= 1
Adequate hematologic function at screening, as follows:
Absolute neutrophil count (ANC) \>= 1,000/microliter

Who the registry excludes

Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation
More than four prior lines of systemic therapy in the metastatic setting
Participants who have wound dehiscence from prior surgeries
Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
Prior history of grade \>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible
Prior allogeneic/autologous bone marrow or solid organ transplant

Public study contact (from the registry)

Wanda A Bell-Farrell

(240) 858-7768

wanda.bell-farrell@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05665361 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05665361?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05665361?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary