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

NCT05440786 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 5 other identifiers: 18434J1S-MC-JP042023-506772-28-002021-004734-11U1111-1302-8098
• Study Type: interventional
• Target: 46
• Locations: 7 countries
• Sites: 29

Brief 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.

Conditions

Sarcoma, Ewing; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis

  PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval.

  From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)

• PFS Assessed by BIRC by Frequentist Analysis

  PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis.

  From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months)

Secondary Outcomes (11)

• PFS Assessed by Investigator by Bayesian Analysis

  From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months)

• PFS Assessed by Investigator by Frequentist Analysis

  From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months)

• Overall Survival (OS)

  From Date of Randomization until Death Due to Any Cause (Up to 26.37 months)

• Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC

  From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months)

• ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator

  From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months)

Study Arms (2)

Abemaciclib + Irinotecan +Temozolomide

EXPERIMENTAL

Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met. * Abemaciclib: 55 mg/m² (milligrams per square meter), administered orally twice daily (BID) for less than (\<18) years or 100 mg administered orally BID for greater than or equal to (≥)18 years. * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Drug: Abemaciclib; Drug: Irinotecan; Drug: Temozolomide

Irinotecan +Temozolomide

EXPERIMENTAL

Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.

Drug: Irinotecan; Drug: Temozolomide

Interventions

Abemaciclib DRUG

Orally

Also known as: LY2835219

Abemaciclib + Irinotecan +Temozolomide

Irinotecan DRUG

IV

Abemaciclib + Irinotecan +Temozolomide; Irinotecan +Temozolomide

Temozolomide DRUG

Orally

Abemaciclib + Irinotecan +Temozolomide; Irinotecan +Temozolomide

Eligibility Criteria

• Age: 1 Year - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• Hemoglobin ≥8 grams per deciLiter (g/Dl) (≥100 grams per Liter \[g/L\])
• Total bilirubin ≤1.5 times (×) upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN
• Creatinine clearance or calculated glomerular filtration rate (GFR) ≥60 milliliters per minute per square meter (Ml/min/m²) or serum creatinine based on age/gender
• Female participants of childbearing potential must have a negative urine or serum pregnancy test

You may not qualify if:

• 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
• Diagnosed and/or treated additional malignancy within 3 years prior to enrollment

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (29)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

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

Los Angeles, California, 90095-1752, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Lifespan Cancer Institute

Providence, Rhode Island, 02906, United States

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

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

Bordeaux, Aquitaine, 33076, France

Location

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, 69373 CEDEX 08, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], 08041, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Related Links

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

MeSH Terms

Conditions

Sarcoma, Ewing; Neoplasm Metastasis

Interventions

abemaciclib; Irinotecan; Temozolomide

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The Bayesian models for PFS by BIRC and PFS by Investigator assume an exponential distribution for the PFS times, which is more restrictive than the distributional assumptions made by the frequentist Cox proportional hazards model.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: September 20, 2022
• Primary Completion: January 15, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AU (3); FR (2); JP (3); DE (3); US (5); IT (2); ES (11)