Ovarian Cancer study: R-DXd vs Bevacizumab
Official title A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
ClinicalTrials.gov ID: NCT07776691
What this study is testing
What is R-DXd?
R-DXd is an investigational targeted therapy being studied as a potential maintenance treatment for ovarian cancer. R-DXd is designed to target specific cancer cells to help control their growth and spread.
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 wants to see whether maintenance therapy with raludotag deruxtecan, alone or combined with bevacizumab, keeps cancer from progressing longer than standard care after surgery and chemotherapy.
- Who it's for
- Women who have advanced ovarian cancer and have finished surgery and chemotherapy.
- What's involved
- Participants will receive the study drug (raludotag deruxtecan) with or without bevacizumab, or standard care, and will have regular clinic visits and tests to monitor cancer status.
- Time commitment
- The study lasts about 2 years, with scheduled visits every few weeks for drug administration and monitoring.
- Phase 3: a large, late-stage study
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
- Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial...
- Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)
- Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of...
- Has provided tumor tissue that is not previously irradiated
- Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the...
You likely can't join if
- Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous...
- Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening
- Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
- Has not recovered from major surgery or has ongoing surgical complications
- Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
See the full eligibility criteria
- Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid)...
- Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)
- Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol
- Has provided tumor tissue that is not previously irradiated
- Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and...
- Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening
- Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
- Has not recovered from major surgery or has ongoing surgical complications
- Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy
- Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by...
- HIV-infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active infection requiring systemic therapy
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Burlington, Massachusetts, United States
- Eugene, Oregon, United States
- Amarillo, Texas, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- Tyler, Texas, United States
- Haifa, Israel
- Tel Aviv, Israel
- Seoul, South Korea
- Tainan, Taiwan
- Lancaster, Lancashire, United Kingdom
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 Washington D.C., District of Columbia, United States; Burlington, Massachusetts, United States; Eugene, Oregon, United States; Amarillo, Texas, United States; Austin, Texas, United States; Fort Worth, Texas, United States and 6 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.