A clinical study to compare MK-2870 with pembrolizumab to pembrolizumab alone in people with lung cancer (MK-2870-007)

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

20 Mar 2024 → ongoing

Decision date (initial)

2024-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-503376-24-00

WHO UTN

U1111-1287-1395

ClinicalTrials.gov

NCT06170788

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Diagnosis, Efficacy, Bioequivalence, Pharmacogenetic, Safety, Pharmacogenomic, Pharmacoeconomic, Dose response

To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to OS

Secondary objectives 6

1. To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR
2. To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to ORR per RECIST 1.1 as assessed by BICR
3. To evaluate DOR per RECIST 1.1 as assessed by BICR of MK-2870 combined with pembrolizumab compared to pembrolizumab alone
4. To evaluate the mean change from baseline in global health status/quality of life (QoL), dyspnea, cough, and chest pain of MK-2870 combined with pembrolizumab compared to pembrolizumab alone
5. To evaluate the time to deterioration in global health status/QoL, dyspnea, cough, and chest pain of MK-2870 combined with pembrolizumab compared to pembrolizumab alone
6. To evaluate the safety and tolerability of MK-2870 combined with pembrolizumab

Conditions and MedDRA coding

Metastatic non-small cell lung cancer (NSCLC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
2. Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
3. Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
4. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
5. A life expectancy of at least 3 months
6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).

Exclusion criteria 23

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Has Grade ≥2 peripheral neuropathy
3. 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 clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
6. Received prior systemic anticancer therapy for their metastatic NSCLC
7. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
8. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
9. Received radiation therapy to the lung within 6 months of start of study intervention
10. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
11. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
12. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
13. Known additional malignancy that is progressing or has required active treatment within the past 3 years
14. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
15. Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary
16. Known hypersensitivity to MK-2870 or other biologic therapy
17. Active autoimmune disease that has required systemic treatment in the past 2 years
18. History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
19. Active infection requiring systemic therapy
20. Concurrent active Hepatitis B and Hepatitis C virus infection
21. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
22. History of allogeneic tissue/solid organ transplant
23. Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS)

Secondary endpoints 13

1. Progression free survival (PFS)
2. Objective Response (OR)
3. Duration of Response (DOR)
4. Change from Baseline in Global Health Status/Quality of Life (QOL) Score [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Items 29 and 30]
5. Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
6. Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31)
7. Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
8. Time to Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Items 29 and 30)
9. TTD Based on Change from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
10. TTD Based on Change from Baseline in Cough Score (EORTC QLQ-LC13 Item 31)
11. TTD Based on Change from Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
12. Percentage of Participants that Experience at Least One Adverse Event (AE)
13. Percentage of Participants who Discontinue Study Treatment Due to an AE

Investigational products

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

Test 2

Auxiliary 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

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ana Nunes

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ana Nunes

Third parties 9

Locations

9 EU/EEA countries · 60 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

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

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

Documents 77 files

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

Application history

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