Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Allison O'Neill, MD
Study ID
NCT04134559
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fibrolamellar Carcinoma
  • Hepatocellular Carcinoma, Childhood
  • Liver Cancer
  • Liver Cancer, Pediatric

Eligibility Criteria

Sex
ALL
Age
0 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered every 3 weeks, at predetermined dose with 21 consecutive days defined as a treatment cycle.

Study Details

This research study is studying an immunotherapy drug (pembrolizumab or KEYTRUDA) as a possible treatment for pediatric hepatocellular carcinoma or hepatocellular neoplasm not otherwise specified (HCN NOS).

Key Dates

Start date
Nov 1, 2020
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Pembrolizumab will be administered every 3 weeks at a dose of 2mg/kg/dose (max: 200mg) with 21 consecutive days defined as a treatment cycle.

Primary Outcome Measure

Immune-related best overall response (irBOR) [ Time Frame: 63 Days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Arun Rangaswami, MD
[email protected]
415-476-3831
Children's Hospital BostonBostonMassachusetts02115
Allison O'Neill, MD
Allison O'Neill, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Allison O'Neill, MD
617-632-4202
Allison O'Neill, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Medical CenterCincinnatiOhio45229
James Geller, MD
[email protected]
513-636-6312
Baylor College of MedicineHoustonTexas77030
Jennifer Foster, MD, MPH
[email protected]
832-824-4646

Find similar trials in San Francisco, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of California San Francisco· San Francisco, CAChildren's Hospital Boston· Boston, MADana Farber Cancer Institute· Boston, MACincinnati Children's Medical Center· Cincinnati, OHBaylor College of Medicine· Houston, TX

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