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Neoplasm MetastasisPhase 1/2NCT06395090

A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)

A Phase 1/2 study testing Pembrolizumab, Favezelimab and Favezelimab/Pembrolizumab in people with Neoplasm Metastasis, run by Merck Sharp & Dohme LLC at 12 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Neoplasm Metastasis
What is being tested?
Pembrolizumab, Favezelimab and Favezelimab/Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
12 sitesin 3 countries
Study dates
15 Jan 2025to 30 Jun 2029
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high (TMB-H)
  • Must have recovered from all AEs from previous anticancer therapies
  • Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)

Who cannot join

  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Show all 16Show fewer
  • Known additional malignancy that is progressing or has required active treatment within the past 1 year
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Active infection requiring systemic therapy
  • Concurrent active Hepatitis B and Hepatitis C virus infection
  • History of allogenic tissue/solid organ transplant
  • Has symptoms of or is being treated for graft versus host disease (GVHD)
  • Has not adequately recovered from major surgery or have ongoing surgical complications
  • Known tumors involving the brainstem

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States9 sites

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2003)

    Fargo, North Dakota, 58122

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 2017)

    Iowa City, Iowa, 52242

  • Children's Mercy Hospital ( Site 2024)

    Kansas City, Missouri, 64108

  • Rutgers Cancer Institute of New Jersey ( Site 2008)

    New Brunswick, New Jersey, 08903

  • Yale-New Haven Hospital ( Site 2012)

    New Haven, Connecticut, 06510

  • Children's Hospital of Philadelphia (CHOP) ( Site 2021)

    Philadelphia, Pennsylvania, 19104

  • Intermountain - Primary Children's Hospital ( Site 2014)

    Salt Lake City, Utah, 84113

  • Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 2015)

    Sioux Falls, South Dakota, 57105

  • New York Medical College ( Site 2023)

    Valhalla, New York, 10595

Other trials in United States

South Korea2 sites

  • Seoul National University Hospital-Pediatrics ( Site 2972)

    Seoul, 03080

  • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 2973)

    Seoul, 05505

Other trials in South Korea

Taiwan1 site

  • National Taiwan University Hospital ( Site 2983)

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment.

There will be no hypothesis testing in this study.

Read the detailed description

The master screening protocol is MK-9999-U01.

Being tested
Pembrolizumab, Favezelimab, Favezelimab/Pembrolizumab, Vibostolimab, Pembrolizumab/Vibostolimab
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475

    IV infusion

  • FavezelimabBiological

    IV infusion

  • Favezelimab/PembrolizumabBiological

    Also called MK-4280A

    IV infusion

  • VibostolimabBiological

    IV infusion

  • Pembrolizumab/VibostolimabBiological

    Also called MK-7684A

    IV infusion

Study groups in NCT06395090
Study groupRoleWhat they receive
Favezelimab + PembrolizumabExperimentalParticipants will receive pembrolizumab and favezelimab via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles. Each cycle is 21 days.
Receives: Biological: Pembrolizumab; Biological: Favezelimab
Favezelimab/PembrolizumabExperimentalParticipants will receive coformulated favezelimab/pembrolizumab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Receives: Biological: Favezelimab/Pembrolizumab
Pembrolizumab + VibostolimabExperimentalParticipants will receive pembrolizumab and vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Receives: Biological: Pembrolizumab; Biological: Vibostolimab
Pembrolizumab/VibostolimabExperimentalParticipants will receive coformulated pembrolizumab/vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.
Receives: Biological: Pembrolizumab/Vibostolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)

    The number of participants who experience toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose will be reported.

    Measured: Up to 21 days

  2. Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 27 months

  3. Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 24 months

  4. Part 1: Area Under the Curve (AUC)

    Blood samples will be collected at specified intervals for the determination of AUC.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  5. Part 1: Maximum Concentration (Cmax)

    Blood samples will be collected at specified intervals for the determination of Cmax.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  6. Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough)

    Blood samples will be collected at specified intervals for the determination of Ctrough.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  7. Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response was assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 57 months

  8. Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by the investigator will be presented.

    Measured: Up to approximately 57 months

Secondary outcomes (13)

  1. Parts 1 and 2: ORR per Lugano Response Criteria by Investigator

    DCR is defined as the percentage of the participants who have stable disease (SD), CR or PR. Response is assessed by CT and PET-CT and evaluated based on Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in SPD for up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% beyond normal). SD is no significant change from baseline in response and no criteria met for progressive disease. DCR as assessed by the investigator will be presented.

    Measured: Up to approximately 57 months

  2. Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR: Disappearance of all target lesions or PR: At least a 30% decrease in the sum of diameters of target lesions or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.] The DCR as assessed by BICR will be presented.

    Measured: Up to approximately 57 months

  3. Parts 1 and 2: DCR per RECIST 1.1 by Investigator

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR: Disappearance of all target lesions or PR: At least a 30% decrease in the sum of diameters of target lesions or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.] The DCR as assessed by BICR will be presented.

    Measured: Up to approximately 57 months

  4. Parts 1 and 2: Duration of Response (DOR) per Lugano Response Criteria by BICR

    For participants who demonstrate a confirmed CR or PR, DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using CT and PET-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in SPD for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by BICR will be presented.

    Measured: Up to approximately 57 months

  5. Parts 1 and 2: DOR per RECIST 1.1 by Investigator

    For participants who demonstrate a confirmed CR: disappearance of all target lesions or PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.

    Measured: Up to approximately 57 months

  6. Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR

    PFS is defined as the time from randomization to documented disease progression or death, whichever occurs first as based on Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). PFS as assessed by BICR will be presented.

    Measured: Up to approximately 57 months

  7. Parts 1 and 2: PFS per RECIST 1.1 by Investigator

    PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.

    Measured: Up to approximately 57 months

  8. Parts 1 and 2: Overall Survival (OS)

    OS is defined as time from first dose of study treatment to death due to any cause.

    Measured: Up to approximately 57 months

  9. Part 2: Area Under the Curve (AUC)

    Blood samples will be collected at specified intervals for the determination of AUC.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  10. Part 2: Maximum Concentration (Cmax)

    Blood samples will be collected at specified intervals for the determination of Cmax.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  11. Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough)

    Blood samples will be collected at specified intervals for the determination of Ctrough.

    Measured: Cycle 1: Predose, postdose, 3, 8, and 15 days postdose; Cycle 2: predose; Cycle 4: predose and postdose; Cycle 5 predose; once predose every 4 cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  12. Parts 1 and 2: Antidrug Antibody (ADA) Levels

    Blood samples will be collected at specified intervals for the determination of ADA levels.

    Measured: Cycle 1, 2, 4, and 5: predose; once every four cycles from Cycle 6 up to Cycle 35. A cycle is 21 days

  13. Parts 1 and 2: Biomarker Levels for Classical Hodgkin Lymphoma (cHL)

    For participants with cHL, the biomarker levels for cHL will be reported.

    Measured: Up to approximately 57 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Why it stopped: development program discontinuation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395090
Sponsor's protocol ID
9999-01B
Other IDs
MK-9999-01B, LIGHTBEAM-U01, 2023-507179-23, U1111-1295-3472, 2023
Status last verified
Apr 2025
First submitted
29 Apr 2024
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Favezelimab and Favezelimab/Pembrolizumab in people with Neoplasm Metastasis, run by Merck Sharp & Dohme LLC at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) (time frame: Up to 21 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06395090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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