Sasanlimab + Palbociclib + Axitinib for Kidney Cancer

(SPARCC Trial)

Not yet recruiting at 1 trial location

Overseen By Bradley McGregor, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stephanie Berg

Must not be taking: Immunosuppressants, Strong CYP3A4/5 inhibitors

Disqualifiers: Untreated brain metastases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 14 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of three drugs—sasanlimab, palbociclib, and axitinib—in treating certain types of advanced kidney cancer. The focus is on clear cell renal cell carcinoma (ccRCC) and translocation renal cell carcinoma (tRCC). Participants suitable for the trial have advanced kidney cancer that cannot be surgically removed or has metastasized. The trial aims to determine if this drug combination can effectively treat these cancer types. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use certain medications like strong CYP3A4/5 inhibitors or inducers, and herbal medications within a specific period before starting the trial. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating the safety of using sasanlimab, palbociclib, and axitinib together to treat advanced kidney cancer. While detailed safety data is not yet available, here is what is known:

1. **Sasanlimab**: This monoclonal antibody is often used in cancer therapy. It is usually well-tolerated, but side effects can include fatigue and infusion reactions, such as fever or chills.

2. **Palbociclib**: This drug helps stop cancer cells from dividing and is already used for some breast cancers. Common side effects include low blood cell counts, fatigue, and nausea.

3. **Axitinib**: This medication blocks a protein that helps tumors grow blood vessels. It is approved for kidney cancer and can cause high blood pressure and fatigue.

Since this trial is in a later stage, earlier studies have shown some safety for the combination. Participants will be closely monitored for any side effects. Always consult the research team about possible side effects to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Sasanlimab, Axitinib, and Palbociclib for kidney cancer because it targets the disease in a unique way. Unlike standard treatments that often focus on one pathway, this combination uses three different mechanisms to attack cancer cells. Sasanlimab is an immune checkpoint inhibitor that helps the immune system better recognize and fight cancer, while Axitinib inhibits blood vessel growth to the tumor, and Palbociclib disrupts cancer cell division. This multi-pronged approach aims to provide a more comprehensive attack on kidney cancer, potentially improving outcomes compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

This trial will study the combination of sasanlimab, palbociclib, and axitinib for kidney cancer. Research has shown that each of these drugs works in ways that might help fight kidney cancer. Sasanlimab helps the immune system find and attack cancer cells. Palbociclib slows the growth of cancer cells. Axitinib cuts off the blood supply to tumors, potentially starving the cancer. While these drugs show promise individually, their combined effect on advanced kidney cancer, such as clear cell renal cell carcinoma, remains under investigation. Early results suggest they might be helpful, but further research is needed to confirm this. ^{1 2 3 5 6}

Who Is on the Research Team?

Stephanie Berg, DO

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). Participants should not have had previous treatments for these conditions. Specific health criteria will be assessed to ensure safety and suitability for the trial.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document.

I can care for myself but may not be able to do active work.

I can swallow pills.

Exclusion Criteria

I have not received any vaccines within 4 weeks before starting sasanlimab, except for inactivated ones.

I do not have an active Hepatitis B or C infection.

Has a personal history of certain cardiovascular conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Sasanlimab, Axitinib, and Palbociclib with imaging every 8 weeks for 16 weeks, then every 12 weeks

14 months

Imaging every 8 weeks for 16 weeks, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation

2 years

Follow-up every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Axitinib
• Palbociclib
• Sasanlimab

Trial Overview

The study tests a combination of three drugs: Sasanlimab, Palbociclib, and Axitinib in patients with metastatic kidney cancer. It aims to determine the effectiveness and safety of this treatment regimen.

How Is the Trial Designed?

Group I: Sasanlimab, Axitinib, and Palbociclib Experimental Treatment 3 Interventions

A Bayesian dose-limiting toxicity plan will be employed per protocol with a monitoring time period of the first two cycles of therapy and starting after the first three participants have started protocol therapy. 25 enrolled participants will complete: * Baseline visit with assessments and imaging * Imaging every 8 weeks for 16 weeks, then every 12 weeks * Cycle 1 Through End of Treatment (28 day cycles): * Day 1: Predetermined dose of Sasanlimab 1x daily * Days 1 through 28: Predetermined dose of Axitinib 2x daily, * Days 8 through 28: Predetermined dose of Palbociclib 1x daily * End of treatment visit * Follow up every 6 months for 2 years after treatment discontinuation

Who Is Running the Clinical Trial?

Stephanie Berg

Lead Sponsor

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07123090

A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in ...

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment ...

2.

dana-farber.org

dana-farber.org/clinical-trials/25-258

A Phase 2 study of sasanlimab, palbociclib and axitinib in ...

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants ...

3.

withpower.com

withpower.com/trial/phase-2-carcinoma-renal-cell-1-2026-34706

Sasanlimab + Palbociclib + Axitinib for Kidney Cancer ...

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/OP-25-00278

Treatment Patterns, Costs, and Outcomes

... outcomes of patients with metastatic renal cell carcinoma receiving pembrolizumab + axitinib vs. ipilimumab + nivolumab. Urol Oncol 41:459 ...

5.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-11193

Palbociclib and Sasanlimab for the Treatment of Advanced ...

Objective: To test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers. Eligibility: People aged 18 years and older with kidney cancer; ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11954509/

Emerging innovative treatment strategies for advanced clear ...

This article reviews key findings that have transformed the way we understand and treat metastatic renal cell carcinoma and highlights novel treatment ...