140 Participants NeededMy employer runs this trial

Anti-PD1 Therapy Duration for Endometrial Cancer

(ASCEND-EC-DCT Trial)

Recruiting at 5 trial locations
EJ
EC
Overseen ByEmmie Cole
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must be taking: Anti-PD1 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

OD

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

Subject is willing and able to comply with study procedures based on the judgement of the investigator
I have finished carboplatin, taxol, and anti-PD1 therapy and will continue anti-PD1 treatment.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
See 3 more

Exclusion Criteria

My tumor's mismatch repair status is unknown.
I am taking other anti-cancer drugs besides chemotherapy and a PD-1 inhibitor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoimmunotherapy

Participants complete the standard course of cytotoxic chemotherapy plus anti-PD1 therapy

Varies

Maintenance Therapy

Participants receive maintenance immunotherapy with anti-PD1 agent therapy; either pembrolizumab or dostarlimab for one or two years

1-2 years

Follow-up

Participants are monitored for progression-free survival, overall survival, and immune-related adverse events

Up to 36 months

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

Group I: anti-PD1 maintenance therapy -1 yearExperimental Treatment1 Intervention
Group II: anti-PD1 maintenance therapy - 2 yearsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Citations

1.

outcomes.com

outcomes.com/

Outcomes | Healthcare Solutions for Pharmacy, Pharma, and ...

See how Outcomes healthcare solutions are connecting payers, pharmacies, and manufacturers to deliver better patient outcomes.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29655837/

Outcomes of Early Liver Transplantation for Patients ... - PubMed

most patients survive for 1 year (94%) and 3 years (84%), similar to patients receiving liver transplants for other indications.

OUTCOME Definition & Meaning

The meaning of OUTCOME is something that follows as a result or consequence. Maternal mortality is a critical and preventable outcome — but prevention requires ...

4.

secure.outcomesmtm.com

secure.outcomesmtm.com/

Outcomes

No information is available for this page.

Child Welfare Outcomes

Explore the annual Child Welfare Outcomes Reports to Congress to review national and state child welfare outcomes using data

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.

Efficacy 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, ...