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New immunotherapy duo aims to outdo chemo for common lymphoma

NCT ID NCT07634471

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 19 times

Summary

This large phase 2/3 trial is testing whether a new immunotherapy drug called MK-1045, when combined with the targeted therapy rituximab, can treat follicular lymphoma better than the current standard of rituximab plus chemotherapy. About 960 people with previously untreated follicular lymphoma will take part. The study will check safety, how well the cancer responds, and whether the new combination helps people live longer without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-1045 (immunotherapy) combined with rituximab (targeted therapy)
What this could lead to
If successful, this could offer a more effective, chemotherapy-free first-line treatment for follicular lymphoma, potentially improving remission rates and delaying disease progression.
What could go wrong
This is an early-to-mid-stage trial (phase 2/3) with 960 participants. The experimental combination may not prove superior to standard chemo, and side effects from immunotherapy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 960 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5. * 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: * 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.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Follicular lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Cancer hospital ( Site 0501)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Box Hill Hospital ( Site 0201)

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Chang Gung Medical Foundation-Linkou Branch ( Site 1002)

    RECRUITING

    Taoyuan, 333, Taiwan

  • City of Hope - Duarte Cancer Center ( Site 1301)

    RECRUITING

    Duarte, California, 91010, United States

  • Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fudan University Shanghai Cancer Center ( Site 0504)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Hacettepe Universite Hastaneleri ( Site 1110)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center ( Site 0701)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Privado Universitario de Córdoba ( Site 0102)

    RECRUITING

    Córdoba, X5016KEH, Argentina

  • Hospital Universitari Vall de Hebron ( Site 0903)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Gregorio Maranon ( Site 0902)

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario de Salamanca ( Site 0906)

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Virgen de la Victoria ( Site 0905)

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Instituto Alexander Fleming ( Site 0105)

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • National Taiwan University Hospital ( Site 1001)

    RECRUITING

    Taipei, 100225, Taiwan

  • Ondokuz Mayıs Universitesi ( Site 1113)

    RECRUITING

    Samsun, 55270, Turkey (Türkiye)

  • SCRI Oncology Partners ( Site 7000)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center ( Site 0801)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Nuestra Senora del Rosario ( Site 0104)

    RECRUITING

    Rosario, Santa Fe Province, S2001SBK, Argentina

  • Sheba Medical Center ( Site 0702)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sisli Florence Nightingale Hastanesi ( Site 1112)

    RECRUITING

    Istanbul, 34381, Turkey (Türkiye)

  • Sourasky Medical Center ( Site 0704)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • University of Kentucky ( Site 1303)

    RECRUITING

    Lexington, Kentucky, 40536, United States

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