IC: * Paclitaxel: IV infusion
* Doxorubicin: IV bolus injection/infusion
Study summary
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.
The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.
All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria
* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
* 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 further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
* 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 chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
* 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 Exclusion Criteria
* 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 with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
* 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 entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
* 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 require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Primary outcome measure(s)
Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) — Up to approximately 3 years
Overall Survival (OS) — Up to approximately 3 years
Trial sites (171)
Facility
City
Region
Status
USAH Mitchell Cancer Inst
Mobile
Alabama
Recruiting
HonorHealth Research Inst
Phoenix
Arizona
Recruiting
Kaiser Permanente SoCal
Irvine
California
Recruiting
CPMC Research Institute
San Francisco
California
Recruiting
Norwalk Hospital
Danbury
Connecticut
Recruiting
Hartford Hospital
Hartford
Connecticut
Recruiting
Norwalk Hospital
Norwalk
Connecticut
Recruiting
MedStar Washington Hospital
Washington D.C.
District of Columbia
Recruiting
SMH - Sarasota - Main Campus
Sarasota
Florida
Recruiting
Women's Care - 9th Ave
St. Petersburg
Florida
Recruiting
Women's Care - Armenia Ave
Tampa
Florida
Recruiting
Emory Winship Cancer Inst.
Atlanta
Georgia
Recruiting
Emory Winship Cancer Inst.
Atlanta
Georgia
Recruiting
Northside Hospital Atlanta
Atlanta
Georgia
Recruiting
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur
Georgia
Recruiting
Endeavor Health NorthShore
Evanston
Illinois
Recruiting
OLOL Cancer Institute
Baton Rouge
Louisiana
Recruiting
Trials365, LLC
Shreveport
Louisiana
Recruiting
Sinai Hospital
Baltimore
Maryland
Recruiting
William Kahlert Reg. Can. Ctr
Westminster
Maryland
Recruiting
UMass Memorial Medical Ctr
Worcester
Massachusetts
Recruiting
Corewell Health
Grand Rapids
Michigan
Recruiting
USOR - Minnesota Oncology-Coon Rapids Clinic
Coon Rapids
Minnesota
Recruiting
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids
Minnesota
Recruiting
USOR - Minnesota Oncology - Edina Clinic
Edina
Minnesota
Recruiting
USOR - Minnesota Oncology/Edina Clinic
Edina
Minnesota
Recruiting
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove
Minnesota
Recruiting
USOR - Minnesota Oncology-Maplewood Clinic
Maplewood
Minnesota
Recruiting
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood
Minnesota
Recruiting
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis
Minnesota
Recruiting
USOR - Minnesota Oncology
Minneapolis
Minnesota
Recruiting
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury
Minnesota
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Morristown Medical Center
Morristown
New Jersey
Recruiting
Atlantic Health - Overlook MC
Summit
New Jersey
Recruiting
Holy Name Medical Center
Teaneck
New Jersey
Recruiting
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street
New York
New York
Recruiting
Perlmutter CC NYU Langone LI
New York
New York
Recruiting
Atrium Health LCI - Morehead
Charlotte
North Carolina
Recruiting
Atrium Health LCI - Ballantyne
Charlotte
North Carolina
Recruiting
+ 131 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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