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Palbociclib + Sasanlimab for Kidney Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had cancer other than kidney cancer in the last 2 years.I have had a bone marrow or organ transplant in the past.I have or had hepatitis B.I am 18 years old or older.I have a history of lung disease or tuberculosis.I am taking high doses of steroids or specific immune system medications.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.My kidney cancer is confirmed as clear cell (ccRCC) or papillary (pRCC).Your blood counts need to be within normal range, with a minimum number of white blood cells, red blood cells, and platelets.I have pRCC and may or may not have received treatment for it.I haven't had treatments for kidney cancer in the last 4 weeks or 5 half-lives.I have had more than two treatments for cancer that has spread.My surgical wound reopened after a previous operation.I do not have chronic diarrhea, IBD, or conditions affecting drug absorption.I have not taken any herbal supplements in the last 14 days.I have advanced kidney cancer with at least one tumor that can be measured.I have ccRCC and have been treated with checkpoint inhibitors and VEGF pathway antagonists.I am fully active and can carry on all my pre-disease activities without restriction.You have had allergic reactions to similar drugs in the past.I've had severe side effects from immunotherapy before.I haven't taken strong CYP3A affecting drugs in the last 21 days or 5 half-lives.You currently have an autoimmune disease that is not well controlled.
- Group 1: 1/ Phase I
- Group 2: 2/Phase II
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants still able to enroll in this research project?
"According to clinicaltrials.gov, the recruiting process for this trial has been deactivated since December 29th 2022. Although recruitment is not taking place at present, there are over 2500 other medical studies that have opened their doors to enrolment."
What outcomes is this investigation seeking to accomplish?
"The primary goal of this 28-day clinical trial is to assess the objective response rate (ORR) of the combination. Additionally, progression-free survival (PFS), safety of the combination and overall survival (OS) will be monitored as secondary outcomes. These data points will be gathered through regular imaging scans every 8 (+/-1) weeks for 32 weeks followed by 12 (+/- 1) week intervals until either disease progression or 6 years after enrollment are recorded. Toxicities or adverse events must also be documented from Day 1 up to 90 days following intervention administration where applicable - only serious side effects related to study interventions reported beyond that window."
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