Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
68
Countries
1
Sites
1
Locally advanced/metastatic renal cell carcinoma
To estimate the objective response rate (ORR) as measured per RECIST 1.1 by investigator determination of pembrolizumab plus epacadostat and SoC (sunitinib or pazopanib)
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Dec 2017 → 5 Jun 2025
- Decision date (initial)
- 2024-04-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC · Incyte Corporation
External identifiers
- EU CT number
- 2024-512016-22-00
- EudraCT number
- 2017-002259-26
- ClinicalTrials.gov
- NCT03260894
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Pharmacodynamic
To estimate the objective response rate (ORR) as measured per RECIST 1.1 by investigator determination of pembrolizumab plus epacadostat and SoC (sunitinib or pazopanib)
Secondary objectives 1
- To evaluate the safety and tolerability of pembrolizumab plus epacadostat and SoC
Conditions and MedDRA coding
Locally advanced/metastatic renal cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10050513 | Metastatic renal cell carcinoma | 100000004864 |
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 6
- Histologic confirmation of locally advanced or metastatic renal cell carcinoma (mRCC) with a clear-cell component with or without sarcomatoid features.
- Must not have received any prior systemic therapy for their mRCC.
- Measurable disease based on Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
- Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
- Karnofsky performance status ≥ 70%.
- Adequate organ function per protocol-defined criteria.
Exclusion criteria 9
- Use of protocol-defined prior/concomitant therapy.
- Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
- History of severe hypersensitivity reaction to study treatments or their excipients.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known additional malignancy that has progressed or has required active treatment in the last 3 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
- History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- Significant cardiac event within 12 months before Cycle 1 Day 1.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
Secondary endpoints 2
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD3432966 · Product
- Active substance
- Sunitinib
- Substance synonyms
- SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 96250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX01 — -
- Marketing authorisation
- EU/1/06/347/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3432965 · Product
- Active substance
- Sunitinib
- Substance synonyms
- SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 96250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX01 — -
- Marketing authorisation
- EU/1/06/347/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP187103 · ATC
- Active substance
- Pazopanib
- Route of administration
- ORAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 1828800 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX03 — PAZOPANIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 10400 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Lulama Rhoda Molife
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Lulama Rhoda Molife
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Merck Sharp & Dohme LLC ORG-100006323
|
Rahway, United States | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8, Code 9 |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 5 | 1 |
| Rest of world
Russian Federation, Turkey, Chile
|
— | 63 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2017-12-27 | 2025-06-04 | 2018-03-05 | 2018-05-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Technical Results Summary 2024-512016-22-00 SUM-135656
|
2026-05-22T20:01:18 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Plain Language Summary of Results 2024-512016-22-00_eng | 2026-05-22T20:01:44 | Submitted | Laypersons Summary of Results |
| Plain Language Summary of Results 2024-512016-22-00_esp | 2026-05-22T20:01:37 | Submitted | Laypersons Summary of Results |
| Plain Language Summary of Results 2024-512016-22-00_hun | 2026-05-22T20:01:32 | Submitted | Laypersons Summary of Results |
| Plain Language Summary of Results 2024-512016-22-00_nor | 2026-05-22T20:01:25 | Submitted | Laypersons Summary of Results |
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Plain Language Results Summary 2024-512016-22-00_eng | 1 |
| Laypersons summary of results (for publication) | Plain Language Results Summary 2024-512016-22-00_esp | 1 |
| Laypersons summary of results (for publication) | Plain Language Results Summary 2024-512016-22-00_hun | 1 |
| Laypersons summary of results (for publication) | Plain Language Results Summary 2024-512016-22-00_nor | 1 |
| Protocol (for publication) | D1_Protocol_2024-512016-22_for pub | 08 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Sunitinib Malate_SM03_for pub | 10APR2024 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC RSI_Pazopanib_for pub | 12OCT2022 |
| Summary of results (for publication) | Technical Results Summary 2024-512016-22-00 | 1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-512016-22_SM01_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_ESP_ES_SM01_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol scientific synopsis_ESP_EN_for pub | outofscope |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | Spain | Acceptable 2024-04-15
|
2024-04-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-28 | Spain | Acceptable 2025-01-27
|
2025-01-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-06 | Spain | Acceptable 2025-06-02
|
2025-06-02 |