Endometrial Cancer study: Rina-S vs IC
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?
An investigational intravenous infusion being studied as a potential treatment for recurrent or progressive endometrial cancer.
Also referred to as GEN1184.
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 study compares how well Rina‑S works against the usual chemotherapy drugs paclitaxel or doxorubicin for patients whose endometrial cancer has come back or kept growing after earlier treatment.
- Who it's for
- Adults with recurrent or progressive endometrial cancer who have already received treatment.
- What's involved
- Participants will be randomly given either Rina‑S or one of the standard chemo drugs. They will receive the drug at the study site and have regular visits for monitoring and tests.
- Time commitment
- The study lasts about 3 years, with each person receiving treatment for an average of 4 to 6 months and attending scheduled visits at the study site.
- 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
- 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...
- Prior induction plus maintenance is considered 1 line of therapy
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.
- 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Irvine, California, United States
- San Francisco, California, United States
- Danbury, Connecticut, United States
- Hartford, Connecticut, United States
- Norwalk, Connecticut, 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
- Evanston, Illinois, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Westminster, Maryland, United States
- Worcester, Massachusetts, United States
+ 134 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, but 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?
This study is enrolling now at Mobile, Alabama, United States; Phoenix, Arizona, United States; Irvine, California, United States; San Francisco, California, United States; Danbury, Connecticut, United States; Hartford, Connecticut, United States and 148 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.