Phase 2 Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma

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

31 Jul 2024 → ongoing

Decision date (initial)

2024-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC · ​Moderna

External identifiers

EU CT number

2023-505177-32-00

WHO UTN

U1111-1291-1851

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS as assessed by investigator

Secondary objectives 3

1. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS
2. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS
3. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to safety and tolerability

Conditions and MedDRA coding

Intermediate-high -risk RCC, high-risk RCC who have undergone nephrectomy, or M1 NED RCC who have undergone nephrectomy and metastasectomy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
2. Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: a. Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0 b. High-risk RCC: pT4, N0, M0; pT any stage, N1, M0 c. M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)
3. Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
4. Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

Exclusion criteria 15

1. Has had a major surgery within 4 weeks prior to randomization.
2. Has residual thrombus post nephrectomy in the vena renalis or vena cava.
3. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
4. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
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. Received prior treatment with a cancer vaccine.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
9. Has a history of brain or bone metastatic lesions.
10. Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
11. Has an active autoimmune disease that has required systemic treatment in the past 2 years.
12. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
13. Has an active infection requiring systemic therapy.
14. History of allogeneic tissue/solid organ transplant.
15. Has not adequately recovered from major surgery or has ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-Free Survival (DFS)

Secondary endpoints 4

1. Distant Metastasis-free Survival (DMFS)
2. Overall Survival (OS)
3. Number of Participants Who Experience an Adverse Event (AE)
4. Number of Participants Who Discontinue Study Treatment Due to an AE

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

Joseph Burgents

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Joseph Burgents

Third parties 10

Locations

5 EU/EEA countries · 19 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 37 files

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

Application history

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