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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.

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507179-23-00
Acronym
MK-9999-01B
Enrollment
2
Registered
2024-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults

Brief summary

Part 1: Area Under the Curve (AUC), Part 1: Maximum Concentration (Cmax), Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs), Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE), Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE, Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR), Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator

Detailed description

Parts 1 and 2: ORR per Lugano Response Criteria by Investigator, Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR, Parts 1 and 2: DCR per RECIST 1.1 by Investigator, Parts 1 and 2: Duration of response (DOR) per Lugano Response Criteria by BICR, Parts 1 and 2: DOR per RECIST 1.1 by Investigator, Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR, Parts 1 and 2: PFS per RECIST 1.1 by Investigator, Parts 1 and 2: Overall Survival (OS), Part 2: Area Under the Curve (AUC), Part 2: Maximum Concentration (Cmax), Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Parts 1 and 2: Antidrug Antibody (ADA) Levels, Parts and 2: Biomarkers for Classical Hodgkin Lymphoma (cHL)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Part 1: Area Under the Curve (AUC), Part 1: Maximum Concentration (Cmax), Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs), Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE), Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE, Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR), Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator

Secondary

MeasureTime frame
Parts 1 and 2: ORR per Lugano Response Criteria by Investigator, Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR, Parts 1 and 2: DCR per RECIST 1.1 by Investigator, Parts 1 and 2: Duration of response (DOR) per Lugano Response Criteria by BICR, Parts 1 and 2: DOR per RECIST 1.1 by Investigator, Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR, Parts 1 and 2: PFS per RECIST 1.1 by Investigator, Parts 1 and 2: Overall Survival (OS), Part 2: Area Under the Curve (AUC), Part 2: Maximum Concentration (Cmax), Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Parts 1 and 2: Antidrug Antibody (ADA) Levels, Parts and 2: Biomarkers for Classical Hodgkin Lymphoma (cHL)

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026