Phase 3 Study of V940 and Pembrolizumab in Resected Melanoma

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

6 Oct 2023 → ongoing

Decision date (initial)

2023-09-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Moderna · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-503652-27-00

WHO UTN

U1111-1287-6366

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Efficacy, Safety

To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to RFS.

Secondary objectives 4

1. To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS
2. To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS.
3. To evaluate the safety and tolerability of V940 plus pembrolizumab.
4. To evaluate V940 plus pembrolizumab versus placebo plus 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

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 11

1. Has resected cutaneous melanoma with histological confirmed stage IIB to IV.
2. Has not received any prior systemic therapy for their melanoma beyond surgical resection.
3. Complete resection that rendered the participant disease-free within 13 weeks prior to the first dose of pembrolizumab.
4. Has a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing.
5. Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases.
6. All suspicious lesions amenable to biopsy should be confirmed negative for malignancy.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
8. Adequate organ function, specimens must be collected within 7 days before the start of study intervention.
9. HBsAg positive participants have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
10. HCV infected participants are eligible if HCV viral load is undetectable at screening.
11. HIV-infected participants must have well controlled HIV on ART.

Exclusion criteria 15

1. Has ocular or mucosal melanoma.
2. Has unresectable in-transit metastases.
3. Clinically significant heart failure.
4. Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample.
5. Has received prior anticancer systemic or immunotherapy or another cancer vaccine or radiotherapy before starting of study intervention.
6. Live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
7. Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
8. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
9. History of CNS metastases and/or carcinomatous meningitis.
10. Active autoimmune disease.
11. Pneumonitis/interstitial lung disease or a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids.
12. Active infection requiring treatment.
13. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
14. Known active hepatitis B or C.
15. Has history of allogeneic 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
3. Number of Participants Experiencing Adverse Events (AEs)
4. Number of Participants Discontinuing Study Treatment Due to AEs
5. Change in Score from Baseline Evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30)
6. Change in Score from Baseline Evaluated by: - Physical Functioning Score (QLQ-C30 Items 1 to 5)
7. Change in Score from Baseline Evaluated by: - Role Functioning Score (QLQ-C30 Items 6 and 7)

Investigational products

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

Test 2

Placebo 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

Dmitri Grebennik

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Dmitri Grebennik

Third parties 11

Locations

10 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

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 137 files

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

Application history

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