Anti-PD1 Therapy Duration for Endometrial Cancer
(ASCEND-EC-DCT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the optimal duration of maintenance immunotherapy for individuals with advanced or recurrent endometrial cancer. It compares one year versus two years of treatment using drugs like pembrolizumab or dostarlimab, which enhance the immune system's ability to fight cancer cells. The goal is to determine if one year of treatment is as effective as two years, potentially reducing side effects and costs. Individuals who have completed a standard round of chemoimmunotherapy for advanced endometrial cancer and are ready for maintenance treatment may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to significant research that could shape future treatment standards.
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 receive additional anti-cancer agents other than the ones specified in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both dostarlimab and pembrolizumab are generally well-tolerated treatments for patients with endometrial cancer. Research indicates that most side effects of dostarlimab are mild, with fewer than 10% of patients experiencing severe side effects. Similarly, pembrolizumab, often used with lenvatinib, significantly reduced the risk of death in patients, with manageable side effects.
These findings suggest that both treatments are generally safe. However, like any medication, they can have side effects. Prospective participants should discuss any concerns with a healthcare provider before deciding to join a trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard chemotherapy options for endometrial cancer, like carboplatin and paclitaxel, the treatments being studied, dostarlimab and pembrolizumab, are part of a newer class of drugs called anti-PD1 therapies. These drugs work by targeting the PD-1 protein on immune cells, effectively unleashing the body's own immune system to attack cancer cells more effectively. Researchers are excited about these treatments because they have the potential to offer longer-lasting control of the disease with potentially fewer side effects compared to traditional chemotherapy. Additionally, this trial is exploring the optimal duration of treatment, which could lead to more personalized and effective care strategies.
What evidence suggests that this trial's treatments could be effective for endometrial cancer?
This trial will compare the duration of anti-PD1 maintenance therapy using pembrolizumab or dostarlimab for endometrial cancer. Studies have shown that pembrolizumab and dostarlimab effectively treat endometrial cancer. These drugs help the immune system fight cancer by blocking a protein that usually prevents it from attacking cancer cells. Research indicates that these treatments can significantly extend the time patients live without their cancer worsening and can also improve overall survival for many with advanced or recurrent cancer. Experts agree on using these therapies for endometrial cancer because previous studies have demonstrated meaningful benefits.678910
Who Is on the Research Team?
Olivia D Lara, MD, MS
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with advanced, metastatic, or recurrent endometrial cancer who have finished standard chemotherapy plus immunotherapy and responded well. Participants must be able to continue maintenance therapy and meet other basic health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoimmunotherapy
Participants complete the standard course of cytotoxic chemotherapy plus anti-PD1 therapy
Maintenance Therapy
Participants receive maintenance immunotherapy with anti-PD1 agent therapy; either pembrolizumab or dostarlimab for one or two years
Follow-up
Participants are monitored for progression-free survival, overall survival, and immune-related adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Dostarlimab
- Pembrolizumab
Trial Overview
The study compares one year versus two years of ongoing anti-PD1 immunotherapy (using pembrolizumab or dostarlimab) after initial treatment. Patients are randomly assigned to either group to see if shorter treatment works as well as longer treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
Participants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Citations
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Dostarlimab for Primary Advanced or Recurrent ...
a 72% lower risk of progression or death in the dMMR–MSI-H population and a 36% lower risk in the overall population.
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gynecologiconcology-online.net
gynecologiconcology-online.net/article/S0090-8258(24)01172-7/fulltextEfficacy and safety of dostarlimab in combination with ...
At the first interim analysis, a 72% reduction in the risk of progression or death (P < 0.0001) was seen with dostarlimab plus carboplatin- ...
Dostarlimab Combo Shows Durable Disease Control in ...
the addition of dostarlimab to chemotherapy improved the 4-year progression-free survival rate to 57.9% (95% CI, 42.3%-70.6%), compared with 15 ...
Efficacy and safety of pembrolizumab in patients with ... - PMC
The trial demonstrated that pembrolizumab combined with lenvatinib significantly reduced the risk of mortality in EC patients compared to conventional ...
Safety and antitumor activity of dostarlimab in patients with ...
We report interim data from patients with endometrial cancer (EC) participating in a phase I trial of single-agent dostarlimab. Methods GARNET, ...
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