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ENDOMETRIAL: PRIOR-PLATINUM/IMMUNOTHERAPY: MK-2870-005

A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Endometrial Cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Post-immunotherapy

Investigational Agent

Sacituzumab tirumotecan

Drug Class

TROP-2 ADC

PI

Todd Tillmanns, MD

Sponsor

Merck Sharp and Dohme

Path

Carcinoma or carcinosarcoma

Key Eligibility Criteria Details

Inclusion Criteria:

  • Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
  • Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
  • Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Exclusion Criteria:

  • Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
  • Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting.
  • Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.
ENDOMETRIAL: ANY STAGE: ADJUVANT: CHEMO-NAIVE: HER2+: NRG-GY026
VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Endometrial, uterine

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab or trastuzumab/pertuzumab

Drug Class

HER2 antibody

PI

Todd Tillmanns, MD

Sponsor

NRG Oncology

Path

Serous carcinoma or carcinosarcoma

Key Eligibility Criteria Details
  • FIGO 2009 stage IA-IVB non-recurrent, chemo-naive, HER2-positive endometrial serous carcinoma or carcinosarcoma
  • Measurable or no-measurable disease allowed
  • ECOG PS 0-2
  • No prior chemo, biologic therapy, or targeted thearpy for treatment of endometrial cancer
  • No prior radiation therapy for endometrial cancer
  • No planned radiation
  • No significant cardiac, lung, or intercurrent illness
  • Patients with prior treatment with hormonal therapy are allowed
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