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CDK4/6 Inhibitor

Palbociclib + Sasanlimab for Kidney Cancer

Phase 1 & 2
Recruiting
Led By Ramaprasad Srinivasan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Adequate renal and hepatic function at screening including Serum creatinine <= 1.5 x upper limit of normal (ULN) OR, if >1.5x ULN, creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2, Total bilirubin <= 1.5 x ULN OR <= 3.0 x ULN in participants with known or suspected Gilbert's syndrome, ALT and AST <= 2.5 x ULN (unless liver metastases are present, then values must be <= 5 x ULN), serologically positive for hepatitis C virus (HCV) are eligible if HCV viral load is undetectable, serologically positive for human immunodeficiency virus (HIV) are eligible if they are on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count >= 200 cells per cubic millimeter, participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms
Must not have
Participants receiving systemic corticosteroids at doses equivalent > 10 mg/daily of prednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, sirolimus, thalidomide, or anti-tumor necrosis factor [anti-TNF] agents
Prior allogeneic/autologous bone marrow or solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests 2 drugs to treat kidney cancer in people aged 18+. Participants take pills and get injections, have tests and scans. Follow-up visits and scans are done for up to 6 years.

Who is the study for?
Adults with advanced kidney cancer, either clear cell renal cell carcinoma (ccRCC) after checkpoint inhibitor therapy and possibly VEGF antagonist treatment, or papillary renal cell carcinoma (pRCC), which may be untreated. Participants need at least one measurable tumor lesion, good physical condition, adequate blood counts and organ function. They must agree to use effective contraception and not breastfeed during the trial.
What is being tested?
The trial is testing a combination of two drugs: Sasanlimab (an injection) given once each cycle, and Palbociclib (a pill) taken daily for 21 days in each 28-day cycle. The study aims to evaluate their effectiveness in treating kidney cancers over cycles lasting up to two years with follow-ups extending up to six years.
What are the potential side effects?
Potential side effects include reactions at the injection site for Sasanlimab, liver issues from both drugs, fatigue, nausea or other digestive problems from Palbociclib. Blood count changes could also occur. Side effects can vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Your kidneys and liver are working well, and you do not have certain viral infections. If you have brain metastasis, you must have completed treatment at least 4 weeks ago with no signs of progression.
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My kidney cancer is confirmed as clear cell (ccRCC) or papillary (pRCC).
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I have advanced kidney cancer with at least one tumor that can be measured.
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I have ccRCC and have been treated with checkpoint inhibitors and VEGF pathway antagonists.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking high doses of steroids or specific immune system medications.
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I have had a bone marrow or organ transplant in the past.
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I have or had hepatitis B.
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I have a history of lung disease or tuberculosis.
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I haven't had treatments for kidney cancer in the last 4 weeks or 5 half-lives.
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I have had more than two treatments for cancer that has spread.
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My surgical wound reopened after a previous operation.
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I do not have chronic diarrhea, IBD, or conditions affecting drug absorption.
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I've had severe side effects from immunotherapy before.
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I haven't taken strong CYP3A affecting drugs in the last 21 days or 5 half-lives.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: To determine RP2D of palbociclib in combination with sasanlimab
Phase II: Objective response rate (ORR)
Secondary study objectives
Disease Control Rate (DCR) defined as PR + CR+ SD in participants re-treated with the study drug combination by RECIST 1.1
overall survival (OS)
progression-free survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment2 Interventions
Sasanlimab and palbociclib at the dose determined in Phase I (RP2D)
Group II: 1/ Phase IExperimental Treatment2 Interventions
Sasanlimab and deescalating doses of palbociclib

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,980 Total Patients Enrolled
Ramaprasad Srinivasan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05665361 — Phase 1 & 2
Kidney Cancer Research Study Groups: 1/ Phase I, 2/Phase II
Kidney Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT05665361 — Phase 1 & 2
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665361 — Phase 1 & 2
~46 spots leftby Jun 2025
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