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CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma

NCT05440786•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.

Eligibility

Age

1 - 39 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor by institutional pathologist. The original pathological report is required. Repeat biopsy at progression is not required
•Refractory disease or confirmed radiological progression or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor
•\-- Must have one measurable or evaluable lesion per RECIST 1.1
•Adequate performance status based on age
•* For participants less than (\<)16 years of age, a Lansky score greater than or equal to (≥)50, or
•* For participants ≥16 years of age, a Karnofsky score ≥50
•Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose and must have recovered from the acute effects
•Adequate hematologic and organ function less than or equal to (≤)14 days prior to Day 1 of Cycle 1:
•* Absolute neutrophil count ≥1000/microliter (µL)
•* Platelets ≥75,000/cubic millimeter (mm³)
+11 more criteria

Exclusion Criteria

•Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
•Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
•Participants who have had allogeneic bone marrow or solid organ transplant
•Surgery: Participants who have had, or are planning to have, the following invasive procedures:
•* Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment
•* Surgical or other wounds must be adequately healed prior to enrollment
•Female participants who are pregnant or breastfeeding
•Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
•Progression during prior treatment with irinotecan and/or temozolomide
•Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
+1 more criteria

Locations (29)

Phoenix Children's Hospital

Phoenix, Arizona, United States

The Regents of the University of California - Los Angeles (UCLA Pediatrics)

Los Angeles, California, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Children's Hospital

Melbourne, Victoria, Australia

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Key Dates

Start Date

September 20, 2022

Primary Completion Date

January 15, 2025

Completion Date

September 1, 2028

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Sarcoma, EwingNeoplasm Metastasis

Interventions

Abemaciclib

DRUG

Irinotecan

DRUG

Temozolomide

DRUG

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Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

Inclusion Criteria

Exclusion Criteria

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