A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer (CAMPFIRE)

March 26, 2026 updated by: Eli Lilly and Company

CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse
        • Principal Investigator:
          • Vivek Bhadri
        • Contact:
          • Phone Number: 61290365375
      • Melbourne, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • Jeremy Lewin
        • Contact:
          • Phone Number: 61385598339
      • Melbourne, Australia, 3052
        • Recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Lisa Orme
      • Westmead, Australia, 2145
        • Not yet recruiting
        • The Sydney Children's Hospitals Network
        • Contact:
          • Phone Number: 61298452138
        • Principal Investigator:
          • Jessica Ryan
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • UCL- Saint Luc
        • Principal Investigator:
          • Benedicte Brichard
        • Contact:
          • Phone Number: 3227642376
      • Ghent, Belgium, 9000
        • Completed
        • Universitair Ziekenhuis Gent
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Principal Investigator:
          • Antoine Italiano
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Principal Investigator:
          • Nadege Corradini
        • Contact:
          • Phone Number: +33478782642
      • Lyon, France, 69008
        • Not yet recruiting
        • Centre Leon Berard
        • Contact:
          • Phone Number: 33478785126
        • Principal Investigator:
          • Jean Yves Blay
      • Paris, France, 75248
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Phone Number: 33144324068
        • Principal Investigator:
          • Sophie Piperno-Neumann
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
        • Principal Investigator:
          • Uta Dirksen
        • Contact:
          • Phone Number: 492017232255
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg
        • Principal Investigator:
          • Simone Hettmer
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Contact:
          • Phone Number: 4940741020622
        • Principal Investigator:
          • Uwe Kordes
  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • IRCCS Istituto Ortopedico Rizzoli
        • Principal Investigator:
          • EMANUELA PALMERINI
        • Contact:
          • Phone Number: 390516366411
      • Candiolo, Italy, 10060
        • Recruiting
        • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
        • Contact:
          • Phone Number: 390119933278
        • Principal Investigator:
          • Massimo Aglietta
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Nazionale dei Tumori
        • Contact:
          • Phone Number: 39022393062
        • Principal Investigator:
          • Andrea Ferrari
      • Padua, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Principal Investigator:
          • Gianni Bisogno
      • Roma, Italy, 00165
        • Recruiting
        • Ospedale Bambino Gesu
        • Contact:
          • Phone Number: 390668592444
        • Principal Investigator:
          • Giuseppe Milano
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Principal Investigator:
          • Antonio Ruggiero
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Principal Investigator:
          • Alexia Bertuzzi
  • Japan
      • Chūōku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Principal Investigator:
          • Chitose Ogawa
        • Contact:
          • Phone Number: 81120023812
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Principal Investigator:
          • Yuhki Koga
        • Contact:
          • Phone Number: 81120023812
      • Kobe, Japan, 650-0047
        • Recruiting
        • Hyogo prefectural kobe children's hospital
        • Principal Investigator:
          • Daiichiro Hasegawa
        • Contact:
          • Phone Number: 81120023812
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Principal Investigator:
          • Hans Gelderblom
      • Utrecht, Netherlands, 3584 CS
        • Recruiting
        • Prinses Maxima Centrum
        • Contact:
          • Phone Number: 31650006353
        • Principal Investigator:
          • Natasha van Eijkelenburg
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Claudia Maria Valverde Morales
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Lucas Moreno Martin Retortillo
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Principal Investigator:
          • Antonio Lopez Pousa
      • Esplugues de Llobregat, Spain, 8950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Principal Investigator:
          • Jaume Mora Graupera
        • Contact:
          • Phone Number: 34932532100
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Pedro Rubio
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Principal Investigator:
          • Maria Cristina Mata Fernandez
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
        • Principal Investigator:
          • Alba Rubio San Simón
      • San Cristóbal de La Laguna, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Principal Investigator:
          • Josefina Cruz Jurado
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Catalina Marquez-Vega
        • Contact:
          • Phone Number: 34955012593
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Principal Investigator:
          • Antonio Juan Ribelles
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
        • Principal Investigator:
          • Robin Jones
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College Hospital - London
        • Principal Investigator:
          • Sandra Strauss
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Martin McCabe
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Royal Manchester Children's Hospital
        • Principal Investigator:
          • Bernadette Brennan
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • Childrens Hospital of Alabama
        • Principal Investigator:
          • Gregory Friedman
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Alok Kothari
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA Medical Center
        • Principal Investigator:
          • Noah Federman
      • Los Angeles, California, United States, 90027
        • Completed
        • Childrens Hospital of Los Angeles
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Principal Investigator:
          • Josephine HaDuong
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Children's Hospital of Colorado
        • Contact:
          • Phone Number: 720-777-6740
        • Principal Investigator:
          • Margaret Macy
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
          • Phone Number: 202-476-4744
        • Principal Investigator:
          • AeRang Kim
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
          • Phone Number: 239-343-5437
        • Principal Investigator:
          • Emad Salman
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Phone Number: 904-953-2000
        • Principal Investigator:
          • Steven Attia
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Children's Healthcare of Atlanta, Inc. at Egleston
        • Contact:
          • Phone Number: 404-785-0910
        • Principal Investigator:
          • Thomas Cash
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H Lurie Children's Hospital of Chicago
        • Contact:
          • Phone Number: 312-227-4834
        • Principal Investigator:
          • David Walterhouse
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5225
        • Active, not recruiting
        • Riley Hospital for Children
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Phone Number: 617-632-5869
        • Principal Investigator:
          • Natalie Collins
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • C.S. Mott Children's Hospital
        • Contact:
          • Phone Number: 734-615-7790
        • Principal Investigator:
          • Rajen Mody
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • University of Minnesota Hospital
        • Principal Investigator:
          • Emily Greengard
        • Contact:
          • Phone Number: 612-626-3593
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
          • Phone Number: 816-302-6808
        • Principal Investigator:
          • Kevin Ginn
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University Medical School
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Phone Number: 212-639-8856
        • Principal Investigator:
          • Emily Slotkin
    • Ohio
      • Columbus, Ohio, United States, 43205-2664
        • Recruiting
        • Nationwide Children's Hosp
        • Principal Investigator:
          • Mark Ranalli
        • Contact:
          • Phone Number: 614-355-1202
    • Oregon
      • Portland, Oregon, United States, 97201
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
          • Phone Number: 503-494-4671
        • Principal Investigator:
          • Katrina Winsnes
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Principal Investigator:
          • Andrew Bukowinski
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Lifespan Cancer Institute
        • Principal Investigator:
          • Bradley DeNardo
        • Contact:
          • Phone Number: 401-829-6552
    • Texas
      • Dallas, Texas, United States, 75390-9063
        • Recruiting
        • University of Texas Southwestern Medical Center at Dallas
        • Principal Investigator:
          • Theodore Laetsch
      • Fort Worth, Texas, United States, 76104-2724
        • Active, not recruiting
        • Cook Children's Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Najat Daw
        • Contact:
          • Phone Number: 713-745-6754
      • Houston, Texas, United States, 77025
        • Not yet recruiting
        • Texas Childrens Hospital
        • Contact:
          • Phone Number: 832-824-4632
        • Principal Investigator:
          • Jodi Muscal
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital Research Foundation
        • Principal Investigator:
          • Catherine Albert
        • Contact:
          • Phone Number: 206-987-2114
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
          • Phone Number: 414-456-4170
        • Principal Investigator:
          • Meghen Browning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.

  • Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  • The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
  • Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects.
  • The participant has adequate hematologic and organ function.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.
  • Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.

Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll.

  • 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 who have active infections requiring therapy.
  • Participants who have had allogeneic bone marrow or solid organ transplant.
  • Participants who have had, or are planning to have, certain invasive procedures.
  • Female participants who are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
Drug: Cyclophosphamide
Administered orally
Drug: Vinorelbine
Administered IV
Active Comparator: Cyclophosphamide + Vinorelbine (DSRCT ISA)
Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Drug: Cyclophosphamide
Administered orally
Drug: Vinorelbine
Administered IV
Experimental: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Drug: Docetaxel
Administered IV
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
Active Comparator: Gemcitabine + Docetaxel (SS ISA)
Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Drug: Docetaxel
Administered IV
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
Experimental: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Drug: Temozolomide
Administered orally
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Irinotecan
Administered IV
Active Comparator: Irinotecan + Temozolomide (ES ISA)
Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Drug: Temozolomide
Administered orally
Drug: Irinotecan
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Allocated to Each ISA
Time Frame: Baseline up to Week 4
Number of Participants Allocated to Each ISA
Baseline up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17304
  • J1S-MC-JAAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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