Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will test to see if the combination of these three drugs is safe and effective in slowing the growth of advanced ccRCC in patients who have not received any prior systemic treatment.
Eligible Conditions
- Carcinoma
- Advanced Clear Cell Renal Cell Carcinoma
Treatment Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Month 100
Median Progression-free survival (PFS)
Month 100
Best Overall Response Rate (ORR)
Year 2
Median Overall Survival (OS)
Trial Safety
Side Effects for
Axitinib
30%Mucositis
10%nausea
10%Fatigue
10%Rash
Trial Design
1 Treatment Group
Axitinib, Avelumab and Palbociclib
1 of 1
Experimental Treatment
25 Total Participants · 1 Treatment Group
Primary Treatment: Axitinib · No Placebo Group · Phase 2
Axitinib, Avelumab and PalbociclibExperimental Group · 3 Interventions: Palbociclib, Avelumab, Axitinib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Avelumab
FDA approved
Axitinib
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Who is running the clinical trial?
PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,940 Total Patients Enrolled
133 Trials studying Carcinoma
69,895 Patients Enrolled for Carcinoma
Bradley A. McGregorLead Sponsor
2 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Carcinoma
99 Patients Enrolled for Carcinoma
Bradley McGregor, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Carcinoma
99 Patients Enrolled for Carcinoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:without any metastatic disease
The biopsy or resection was performed within 1 year of registration without any metastatic disease present.
The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained
You may choose to have additional tumor biopsies for research purposes prior to starting therapy, after 2 months of therapy and at end of treatment.
This means that your absolute neutrophil count is greater than or equal to 1.5x109/L.
Renal cell carcinoma that is too advanced to be surgically removed and has a clear cell component, regardless of the presence of sarcomatoid histology, is accepted.
We can provide an archival FFPE tumor tissue block from the primary diagnosis specimen (if available and not provided per above)
The text is discussing how to measure disease progression using RECIST 1.1
The patient has an ECOG performance status of ≤2 (Karnofsky score of ≥60%, see Appendix A).
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
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