A clinical study of MK-1084 in people with advanced solid tumors (MK 1084-014)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Nov 2025 → ongoing

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-521737-91-00

WHO UTN

U1111-1320-8626

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

1. To evaluate ORR for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR
2. To compare MK-1084 plus cetuximab versus MK-1084 with respect to ORR per RECIST 1.1 as assessed by BICR
3. To evaluate the safety and tolerability of MK-1084 and MK-1084 plus cetuximab

Secondary objectives 3

1. To evaluate OS for MK-1084 and MK-1084 plus cetuximab
2. To evaluate DOR for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR
3. To evaluate PFS for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR

Conditions and MedDRA coding

Neoplasm malignant with KRAS G12C mutation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
2. Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion criteria 5

1. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
2. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
3. Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
4. Has active infection, other than those permitted per protocol, requiring systemic therapy
5. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Objective Response Rate (ORR)
2. Number of Participants Who Experience One or More Adverse Events (AEs)
3. Number of Participants Who Discontinue Study Intervention Due to an AE

Secondary endpoints 3

1. Overall Survival (OS)
2. Duration of Response (DOR)
3. Progression-free Survival (PFS)

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Rohini Singh

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Rohini Singh

Third parties 8

Locations

9 EU/EEA countries · 25 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 57 files

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

Application history

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