SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sarcoma Alliance for Research through Collaboration
Study ID
NCT04803877
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Osteosarcoma
  • Osteosarcoma Metastatic
  • Osteosarcoma Recurrent
  • Osteosarcoma in Children

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Regorafenib 40 MG — DRUG
    For subjects age 18 and older, Regorafenib will be administered as 80mg oral once daily on Cycle 1, Days 1-7 and then escalated to 120 mg once daily for Cycle 1, Days 8-21 if no Grade 2 or above regorafenib adverse events occur. For subsequent cycles, the highest tolerated dose will be taken once daily on days 1-21 of each 28-day cycle.
  • Regorafenib 20MG — DRUG
    For subjects younger than 18 years, Regorafenib will be administered as 60mg/m2/dose (rounded to the nearest 20mg, maximum dose of 80mg) once daily for Cycle 1, Days 8-21 if no Grade 2 or above regorafenib-related adverse events occur. For subsequent cycles, the highest tolerated dose will be taken once daily on days 1-21 of each 28-day cycle.
  • Nivolumab — DRUG
    For subjects age 18 and older, Nivolumab will be administered at 480mg IV over 30 min every 28 days. For subjects younger than 18 years, Nivolumab 3mg/kg (maximum dose 240mg) will be administered IV over 30 minutes on day 1 and 15 of each 28-day cycle.

Study Details

A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.

Key Dates

Start date
Jun 4, 2021
Status verified
Oct 2025
Primary completion
Nov 30, 2025
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Regorafenib and Nivolumab

Primary Outcome Measure

Compare the 4-month progression-free survival rate to historical controls [ Time Frame: Approximately 4 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
University of MiamiMiamiFlorida33136-
Johns HopkinsBaltimoreMaryland21287-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Cincinnati Children'sCincinnatiOhio45229-
Oregon Health and Sciences UniversityPortlandOregon97239-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CAUniversity of Miami· Miami, FLJohns Hopkins· Baltimore, MDUniversity of Michigan· Ann Arbor, MIUniversity of Minnesota· Minneapolis, MNCincinnati Children's· Cincinnati, OH

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