Research & Innovation

Uterine Clinical Trials

Clinical Trials

Merck MK2870-033 / GOG 3119 (TroFuse-033)

A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (NCT06952504).

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 test the experimental drug sacituzumab tirumotecan (sac-TMT) when given in combination with pembrolizumab (pembro) in people with a specific type of endometrial cancer. All participants will receive pembro and chemotherapy per standard of care when starting the study. After this induction phase, you may receive sac-TMT, pembro or a combination of sac-TMT and pembro depending on your health and disease status when you complete the induction phase.

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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:

  • Histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
  • Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
  • Has received no prior systemic therapy for endometrial carcinoma except the following conditions: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
  • No history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
  • No history of uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • No active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • No prior anti-PD-1, anti-PD-L1, anti-PD-L2, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate
  • Participants must not be a candidate for curative-intent surgery or curative-intent radiotherapy at the time of study enrollment

 

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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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