Research & Innovation

Uterine Clinical Trials

Clinical Trials

Merck MK-4280A-010 Cohort B

A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010) (NCT 06036836).

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

The purpose of this research study is to test the safety and efficacy of the study drug MK-4280A in patients with certain kinds of solid tumors. For Cohort B, participants will receive either the investigational agent MK-4280A or pembrolizumab plus lenvatinib for endometrial (uterine) cancer that has been previously treated and does not have dMMR cells as determined on the tissue pathology report.

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Eligibility Criteria

Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must have a histologically confirmed diagnosis of endometrial cancer (EC) that is not dMMR (pMMR)
  • Patients must have documented evidence of stage IVB, recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
  • Must have radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
  • Up to 2 lines of platinum-based chemotherapy is allowed if 1 regimen was given in the neoadjuvant or adjuvant setting
  • Prior RT is allowed
  • No prior use of anti-PD-1, anti-PD-LD1 or anti-PD-L2 agents or other use of stimulatory or coinhibitory T-cell receptors (ex. CTLA-4,OX-40, CD137) is allowed
  • Prior use of bevacizumab is allowed
  • Patients must have adequate organ function, ECOG PS of 0-1 and greater than 3 months life expectancy
  • Patients must have adequately controlled blood pressure with or without antihypertensive medications and adequate cardiac function measured by MUGA or ECHO

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NRG-GY026

Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Herceptin Hylecta or Pertuzumab, Trastuzumab and PHESGO in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma (NCT 05256225).

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

This study is being done to compare the usual treatment alone to the usual treatment plus Herceptin Hylecta or PHESGO. The addition of trastuzumab / Herceptin Hylecta or trastuzumab / pertuzumab / PHESGO to the usual treatment could prevent your cancer from returning or shrink your cancer. This study will help the study doctors find out if the different approach is better, the same or worse than the usual approach. The usual approach is chemotherapy with two agents called paclitaxel and carboplatin.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Treatment naïve (not previously treated) stage IA-IVB endometrial serous carcinoma or endometrial carcinosarcoma
  • All patients must have tumors that are HER2 positive (ex. 3+ by IHC, 2+ by ISH)
  • Patients may have measurable disease, non-measurable disease, or no measurable disease on CT or MRI imaging
  • For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium
  • Patients may not have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
  • Patients may not have received prior radiation therapy for treatment of endometrial carcinoma
  • Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment but must be determined at time of study registration

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