Endometrial Cancer
GOG-3104: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Description
this is a randomized, open-label, global Phase 3 study designed to assess the effect of SG compared with TPC (doxorubicin or paclitaxel) in participants with recurrent/persistent endometrial cancer who have received prior treatment with platinum-based chemotherapy and anti-programmed cell death protein 1/programmed cell death ligand 1 (anti-PD-1/PD-L1) therapy. Prior anti-PD-1/PD-L1 therapy is not required in participants who have medical comorbidities precluding anti-PD-1/PD-L1 therapy, or for whom anti-PD-1/PD-L1 therapy is not available as a standard-of-care treatment in any line of therapy according to local standards; however, enrollment of participants who have not received prior anti-PD-1/PD-L1 therapy will be capped at approximately 10%.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Participants must meet all of the following inclusion criteria to be eligible for participation in this study (no waivers for participant eligibility will be offered or permitted):
1. Participants assigned female at birth, 18 years of age or older (or minimum age according to country-specific requirements), and able to understand and give written informed consent.
2. Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
3. Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
- Neoadjuvant and/or adjuvant therapy is considered 1 prior line of systemic therapy.
- Prior monoclonal antibodies or targeted therapies, including but not limited to bevacizumab, poly (adenosine diphosphate-ribose) polymerase inhibitors, trastuzumab, will count as a line of treatment if given as a single agent with the intent of controlling disease. If these agents are given in combination with chemotherapy and continued as maintenance monotherapy, they will not be counted as a separate line of treatment.
- There is no restriction regarding prior hormonal or hormonal-based therapy. Hormonal or hormonal-based therapy does not count as a line of therapy.
- For participants who are ineligible for anti-PD-1/PD-L1 therapy due to medical comorbidities, or if anti-PD-1/PD-L1 agents are not available as standard-of-care therapy in any line of treatment according to local standards, prior treatment with an anti-PD-1/PD-L1 agent is not required.
4. Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
5. Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria by investigator assessment.
- If a participant has disease based on pleural effusion or ascites alone (with no other radiologically evaluable lesions), this must be cytologically confirmed.
6. Documented disease progression by CT or MRI during or after the most recent therapy per RECIST v1.1 criteria by investigator assessment.
7. Availability of tumor tissue from an archival or fresh biopsy for assessment of Trop-2 and other study biomarkers. Tissue submission should be in the form of a formalin-fixed paraffin-embedded block (preferably) or > 20 freshly, unstained slides. Tissue must be submitted within 4 weeks of randomization.
- If archival tumor tissue is available, it should preferably be from the most recently available tumor biopsy (obtained ideally within 12 months prior to randomization), from a locally recurrent or metastatic site. If archival tissue is not available, a fresh biopsy, preferably from a locally recurrent or metastatic site should be performed before randomization. Fine needle aspirates, bone biopsies, and cytology samples are not suitable samples. If < 20 unstained slides are available, and it is not clinically feasible to obtain a new biopsy, the participant may still be eligible upon consultation with the sponsor medical monitor.
8. Eastern Cooperative Oncology Group performance status score of 0 or 1.
9. Meet the following organ function requirements:
Organ Function | Status | Parameters |
Adequate hematologic counts | Blood transfusion or growth factor support are not allowed within 14 days prior to screening laboratory parameters. |
|
Adequate hepatic function | — |
|
Creatinine clearance | — | > 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976} |
Coagulation | — | International normalized ratio/prothrombin time and partial thromboplastin time or activated partial thromboplastin time < 1.5 x ULN unless participant is currently receiving therapeutic anticoagulation therapy |
10. Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
11. Life expectancy of > 3 months
12. Willing and able to comply with the requirements and restrictions in this protocol.
Start Date
Tuesday, December 17, 2024
Principal / Contact Name
Sarah E. Gill, MD