Avelumab + Talazoparib/Axitinib for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing Avelumab alone and with Talazoparib or Axitinib to treat endometrial cancer that has returned or spread. It aims to see if these drugs can help patients whose cancer hasn't responded to other treatments by boosting the immune system, stopping DNA repair in cancer cells, or blocking blood vessel growth. These drugs are being explored for their potential in treating endometrial cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain herbal products or medications that strongly affect liver enzymes. It's best to discuss your current medications with the study team to see if any adjustments are needed.
How is the drug Avelumab + Talazoparib/Axitinib unique for treating endometrial cancer?
Avelumab is a unique drug for endometrial cancer because it is an immune checkpoint inhibitor that targets the PD-L1 pathway, potentially enhancing the body's immune response against cancer cells. This combination with Talazoparib or Axitinib is novel as it explores the synergy between immune modulation and other targeted therapies, which is different from the more established treatments like pembrolizumab and lenvatinib.12345
What data supports the effectiveness of the drug combination Avelumab + Talazoparib/Axitinib for Endometrial Cancer?
Research shows that drugs targeting the PD-1/PD-L1 pathway, like pembrolizumab, have been effective in treating certain types of advanced endometrial cancer, especially when combined with other treatments. This suggests that similar drugs, such as Avelumab, might also be effective in combination therapies for endometrial cancer.12678
Who Is on the Research Team?
Panagiotis Konstantinopoulos, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for women with recurrent or persistent endometrial cancer who haven't used PD-1/PD-L1 pathway drugs, PARP inhibitors (for certain cohorts), or axitinib. They must be adults with at least one prior chemotherapy regimen, not pregnant/breastfeeding, and have normal organ/marrow function. Participants need measurable disease by RECIST 1.1 standards and no severe illnesses that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Avelumab alone or in combination with Talazoparib or Axitinib for recurrent or metastatic endometrial cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed for survival status from registration through up to 3 years after removal from study intervention
What Are the Treatments Tested in This Trial?
Interventions
- Avelumab
- Axitinib
- Talazoparib
Avelumab is already approved in European Union, United States, Japan for the following indications:
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Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Pfizer
Industry Sponsor
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