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Compares treatment options for Endometrial Cancer
Official title Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
ClinicalTrials.gov ID: NCT07166094
What this study is testing
What is Rina-S?
Rina-S is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as Rinatabart Sesutecan, PRO1184.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Key Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding...
- Participants must have received at least 1, but not more than 3, prior lines of therapy:
- Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in...
- If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be...
- Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of...
You likely can't join if
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease...
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate...
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at...
See the full eligibility criteria
- Key Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior...
- Participants must have received at least 1, but not more than 3, prior lines of therapy:
- Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
- If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for...
- Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based...
- Prior induction plus maintenance is considered 1 line of therapy
- Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
- Participants must have progressed radiographically on or after their most recent line of therapy Key
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies...
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study...
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- Washington D.C., District of Columbia, United States
- Sarasota, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Westminster, Maryland, United States
- Grand Rapids, Michigan, United States
- Coon Rapids, Minnesota, United States
- Edina, Minnesota, United States
- Maple Grove, Minnesota, United States
- Maplewood, Minnesota, United States
- Minneapolis, Minnesota, United States
- Woodbury, Minnesota, United States
- St Louis, Missouri, United States
- Teaneck, New Jersey, United States
+ 82 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; Washington D.C., District of Columbia, United States; Sarasota, Florida, United States; St. Petersburg, Florida, United States; Tampa, Florida, United States and 96 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.