Clinical trial of MK-7648A in adults and children with skin cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Aug 2023 → 24 Sep 2025

Decision date (initial)

2023-07-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2022-501417-31-01

WHO UTN

U1111-1280-3661

ClinicalTrials.gov

NCT05665595

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To compare MK-7684A to pembrolizumab with respect to RFS

Secondary objectives 4

1. To compare MK-7684A to pembrolizumab with respect to DMFS.
2. To compare MK-7684A to pembrolizumab with respect to OS.
3. To evaluate the safety and tolerability of MK-7684A and pembrolizumab.
4. To evaluate MK-7684A to pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30.

Conditions and MedDRA coding

melanoma

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
2. Has not received any prior systemic therapy for melanoma beyond surgical resection
3. Has had no more than 12 weeks between final surgical resection and randomization
4. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Exclusion criteria 13

1. Has ocular, mucosal, or conjunctival melanoma
2. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
3. Has not adequately recovered from major surgical procedure or has ongoing surgical complications
4. Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
5. Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
6. Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
9. Has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis
10. Has an active autoimmune disease that has required systemic treatment in past 2 years
11. Has an active infection requiring systemic therapy
12. Has known concurrent active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) and Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
13. Has had an allogenic tissue/solid organ transplant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Recurrence-Free Survival (RFS)

Secondary endpoints 7

1. Distant Metastasis-Free Survival (DMFS)
2. Overall Survival (OS)
3. Number of Participants Who Experienced at Least One Adverse Event (AE)
4. Number of Participants Who Discontinued Study Treatment Due to an AE
5. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
6. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
7. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

Investigational products

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

Test 1

Comparator 1

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

Rohit Lal

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Rohit Lal

Third parties 6

Locations

9 EU/EEA countries · 62 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 124 files

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

Application history

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