Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
139
Countries
2
Sites
6
Colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC)
1. To evaluate the safety and tolerability of MK-2870 monotherapy or in combination with other anticancer agents 2. To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR
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
- 1 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-508703-21-00
- WHO UTN
- U1111-1298-8273
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response, Efficacy, Pharmacoeconomic, Pharmacokinetic, Diagnosis, Safety, Prophylaxis, Pharmacogenomic, Pharmacogenetic
1. To evaluate the safety and tolerability of MK-2870 monotherapy or in combination with other anticancer agents
2. To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR
Secondary objectives 3
- 1. To evaluate the DOR per RECIST 1.1 as assessed by BICR
- 2. To evaluate PFS per RECIST 1.1 as assessed by BICR
- 3. To evaluate OS
Conditions and MedDRA coding
Colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10010029 | Colorectal cancer NOS | 10029104 |
| 20.0 | LLT | 10028982 | Neoplasm biliary tract | 10029104 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504918-29-00 | An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer | Merck Sharp & Dohme LLC |
| 2023-508323-12-00 | A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20) | Merck Sharp & Dohme LLC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1. Has one of the following cancers: • Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer • Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer • Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer • Advanced and/or unresectable BTC and has not received prior therapy for the cancer
- 2. For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment
Exclusion criteria 3
- 1. History of severe eye disease
- 2. For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention.
- 3. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- 1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
- 2. Number of Participants Who Experience One or More Adverse Events (AEs)
- 3. Number of Participants Who Discontinue Study Treatment Due to an AE
- 4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Secondary endpoints 3
- 1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
- 2. Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
- 3. Overall Survival (OS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD12802980 · Product
- Active substance
- Sacituzumab Tirumotecan
- Substance synonyms
- Humanised IgG1 monoclonal antibody against TROP2, conjugated to KL610023, SKB264, MK-2870, Humanised IgG1 monoclonal antibody against TROP2, conjugated to sulfonylpyrimidine-polyethyleneglycol-lysine-methanesulfonyl belotecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11447874 · Product
- Active substance
- Sacituzumab Tirumotecan
- Substance synonyms
- Humanised IgG1 monoclonal antibody against TROP2, conjugated to KL610023, SKB264, MK-2870, Humanised IgG1 monoclonal antibody against TROP2, conjugated to sulfonylpyrimidine-polyethyleneglycol-lysine-methanesulfonyl belotecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- 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
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- CDDP, Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132603 · ATC
- Active substance
- Calcium Folinate
- Substance synonyms
- LEUCOVORIN CALCIUM
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139914 · ATC
- Active substance
- Calcium Folinate
- Substance synonyms
- LEUCOVORIN CALCIUM
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- ORAL AND IV
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL AND IV
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
H02AB · Product
- Pharmaceutical form
- PHF00231MIG
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
A02BA · Product
- Active substance
- H2-Receptor Antagonists
- Pharmaceutical form
- -
- Route of administration
- ORAL AND IV
- Authorisation status
- Authorised
- ATC code
- A02BA — H2-Receptor Antagonists
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- Johnathan Ebben
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Johnathan Ebben
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Infinity Biologix LLC ORG-100040369
|
Piscataway, United States | Laboratory analysis |
| Roche ORL-000013317
|
Oro Valley, Arizona, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Pra International ORG-100032850
|
Blue Bell, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Almac Diagnostic Services Limited ORG-100040447
|
Craigavon, United Kingdom (Northern Ireland) | Laboratory analysis |
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 9 | 3 |
| Spain | Ongoing, recruiting | 11 | 3 |
| Rest of world
Taiwan, United States, Australia, China, Chile, Canada, Korea, Republic of, United Kingdom, Switzerland, Japan, Turkey
|
— | 119 | — |
Investigational sites
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Dipartimento di Ematologia e Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica I, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica, Largo Agostino Gemelli 8, 00168, Rome
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Central De Asturias
Medical Oncology, Avenida De Roma S/n, 33011, Oviedo
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 |
|---|---|---|---|---|---|
| Italy | 2024-08-01 | 2024-08-01 | |||
| Spain | 2024-08-05 | 2024-08-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508703-21_SM06_for pub | 08R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_for pub | 12MAR2024R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 13MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_SM02_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ITA_IT_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM07_for pub | AM05 5.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM07_for pub | AM05v5.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 16SEP2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 16SEP2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM06_for pub | 0.00R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_5-FLUOROURACIL Hospira UK LTD_SM07_for pub | 20JAN2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CISPLATIN Sandoz Limited_SM07_for pub | 12NOV2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Cisplatin_SM05_for pub | 08NOV2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Leucovorin_SM02_for pub | 26SEP2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Levoleucovorin_for pub | 06NOV2020 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab_SM05_for pub | 16APR2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508703-21_ESP_ES_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508703-21_ITA_IT_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508703-21_SM06_for pub | 3.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-20 | Spain | Acceptable 2024-07-08
|
2024-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-10 | Spain | Acceptable 2024-12-10
|
2024-12-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-11 | Spain | Acceptable 2025-05-05
|
2025-05-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-15 | Spain | Acceptable 2025-06-20
|
2025-06-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-12 | Spain | Acceptable 2025-10-09
|
2025-10-13 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-29 | Spain | Acceptable 2025-10-09
|
2025-10-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-16 | Spain | Acceptable 2026-03-05
|
2026-03-06 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-04-08 | Spain | Acceptable 2026-05-18
|
2026-05-20 |