Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
38
Countries
2
Sites
7
Follicular Lymphoma
1. Part 1: To evaluate the safety and tolerability of MK-1045 in combination with rituximab. 2. Part 1: To evaluate MK-1045 plus rituximab with respect to CR per Lugano response criteria as assessed by physician investigator. 3. Part 2: To compare MK-1045 plus rituximab with physician’s choice chemotherapy plus rituxim…
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
- 19 Jun 2026 → ongoing
- Decision date (initial)
- 2026-06-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2025-522777-10-00
- WHO UTN
- U1111-1324-3019
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Pharmacogenetic, Therapy, Efficacy, Safety, Pharmacogenomic, Dose response
1. Part 1: To evaluate the safety and tolerability of MK-1045 in combination with rituximab.
2. Part 1: To evaluate MK-1045 plus rituximab with respect to CR per Lugano response criteria as assessed by physician investigator.
3. Part 2: To compare MK-1045 plus rituximab with physician’s choice chemotherapy plus rituximab with respect to PFS per Lugano response criteria as assessed by BICR.
Secondary objectives 10
- Part 1: To evaluate MK-1045 plus rituximab with respect to OR per Lugano response criteria as assessed by physician investigator.
- Part 1: To evaluate the duration of CR with MK-1045 plus rituximab per Lugano response criteria as assessed by physician investigator.
- Part 1: To characterize the PK of MK-1045.
- Part 2: To evaluate MK-1045 plus rituximab with physician’s choice chemotherapy plus rituximab with respect to CR at 30 months per Lugano response criteria as assessed by BICR.
- Part 2: To evaluate MK-1045 plus rituximab with physician’s choice chemotherapy plus rituximab with respect to OR per Lugano response criteria as assessed by BICR.
- Part 2: To evaluate MK-1045 plus rituximab with physician’s choice chemotherapy plus rituximab with respect to OS.
- Part 2: To evaluate MK-1045 plus rituximab with physician’s choice chemotherapy plus rituximab with respect to EFS per Lugano response criteria as assessed by BICR.
- Part 2: To evaluate the duration of CR with MK-1045 plus rituximab versus physician’s choice chemotherapy plus rituximab per Lugano response criteria as assessed by BICR.
- Part 2: To evaluate the safety and tolerability of MK-1045 plus rituximab.
- Part 2: To evaluate MK-1045 plus rituximab with respect to changes from baseline in HRQoL assessments using the FACT Lym.
Conditions and MedDRA coding
Follicular Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10029473 | Nodular (follicular) lymphoma | 10029104 |
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
- Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL).
- Has radiographically measurable disease per the Lugano Response Criteria.
- Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
- If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion criteria 14
- Has received prior systemic anticancer therapy or radiotherapy for FL.
- Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
- Has FL that has transformed into a more aggressive type of lymphoma.
- History or presence of clinically relevant central nervous system (CNS) diseases.
- Has history of serious cardiovascular and cerebrovascular diseases.
- Is HIV-infected with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active CNS lymphoma or involvement.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Part 1: Number of Participants Who Experience an Adverse Event (AE)
- Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
- Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
- Part 1: Complete Response (CR) Rate
- Part 2: Progression-Free Survival (PFS)
Secondary endpoints 15
- Part 1: Objective Response Rate (ORR)
- Part 1: Duration of CR
- Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045
- Part 1: Maximum Concentration (Cmax) of MK-1045
- Part 1: Trough Concentration (Ctrough) of MK-1045
- Part 2: CR Rate at 30 Months
- Part 2: ORR
- Part 2: Overall Survival (OS)
- Part 2: Event-Free Survival (EFS)
- Part 2: Duration of CR
- Part 2: Number of Participants Who Experience an AE
- Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
- Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
- Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score
- Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD12842756 · Product
- Active substance
- MK-1045
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD12842757 · Product
- Active substance
- MK-1045
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ruxience 100 mg concentrate for solution for infusion
PRD7980793 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ruxience 500 mg concentrate for solution for infusion
PRD7980794 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 500 mg concentrate for solution for infusion
PRD12523544 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/003
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 100 mg concentrate for solution for infusion
PRD5065907 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/002
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
SCP106382672 · ATC
- Active substance
- Cyclophosphamide
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 6000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP119562649 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107216203 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 320 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP107974752 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 320 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1137788 · ATC
- Active substance
- Vinorelbine
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1.4 mg/m2 milligram(s)/sq. meter
- Max total dose
- 11.2 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP20211730 · ATC
- Active substance
- Bendamustine Hydrochloride
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1080 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AA09 — BENDAMUSTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SCP176238 · ATC
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Route of administration
- OTHER USE
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — TOCILIZUMAB
- 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
- Pallavi Pillai
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Pallavi Pillai
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 2 | 2 |
| Spain | Authorised, recruiting | 3 | 5 |
| Rest of world
Taiwan, China, Argentina, Canada, Israel, Korea, Republic of, Australia, United States, Turkey, Chile
|
— | 33 | — |
Investigational sites
Centre Hospitalier Regional Universitaire De Tours
Hematology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Universitaire De Dijon
Hematology, 14 Rue Paul Gaffarel, 21000, Dijon
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Complejo Asistencial Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
Hematology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
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 | 2026-06-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522777-10_IN-RFI003_for pub | 02R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 05FEB2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_IN_for pub | 04FEB2026 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_IN-RFI004_for pub | AM01v1-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Partie 1_FRA_FR_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_Partie 2_FRA_FR_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Truxima_Celltrion Healtcare_Ltd_IN_for pub | 10JUN2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-522777-10_ESP_ES_IN-RFI003_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-522777-10_FRA_FR_IN-RFI003_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-522777-10_IN-RFI003_for pub | 4.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-18 | Spain | Acceptable 2026-06-05
|
2026-06-09 |