MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Mar 2024 → ongoing

Decision date (initial)

2024-02-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-504816-14-00

WHO UTN

U1111-1288-7581

ClinicalTrials.gov

NCT06132958

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Safety, Diagnosis, Therapy, Efficacy, Pharmacokinetic, Pharmacogenetic, Pharmacoeconomic, Pharmacodynamic

1. To compare MK-2870 to Treatment of Physician’s Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
2. To compare MK-2870 to TPC with respect to overall survival (OS)

Secondary objectives 4

1. To compare MK-2870 to TPC with respect to objective response rate (ORR) per RECIST 1.1 by BICR in participants with measurable disease at baseline
2. To evaluate MK-2870 versus TPC with respect to duration of response (DOR) per RECIST 1.1 by BICR in participants with measurable disease at baseline
3. To evaluate the safety and tolerability of MK-2870
4. To evaluate health-related quality of life (QoL) outcome for MK-2870 versus TPC using the EORTC QLQ-C30

Conditions and MedDRA coding

Endometrial cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
2. Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by BICR.
3. 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 11

1. Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
2. Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
3. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
4. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
5. Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. This includes:1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
6. Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.
7. Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
8. Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
9. Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
10. Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
11. Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
2. Overall Survival (OS)

Secondary endpoints 5

1. Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
2. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
3. Number of Participants Who Experience One or More Adverse Events (AEs)
4. Number of Participants Who Discontinue Study Intervention Due to an AE
5. Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Kristina Woodhouse

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Kristina Woodhouse

Third parties 9

Locations

15 EU/EEA countries · 72 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 137 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

23 submissions — initial application plus substantial / non-substantial modifications