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NeoplasmsPhase 2CAMPFIRENCT05999994

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

A Phase 2 study testing Ramucirumab, Cyclophosphamide and Vinorelbine in people with Neoplasms and Child, run by Eli Lilly and Company at 72 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 39 years
Conditions the study is for
Neoplasms, Child, Adolescent
What is being tested?
Ramucirumab, Cyclophosphamide and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
72 sitesin 10 countries
Study dates
22 Jan 2020to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

72 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

72 sites in 10 countries

United States30 sites, 25 recruiting

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    734-615-7790

    Rajen Mody

    Not yet recruiting

  • Children's Healthcare of Atlanta, Inc. at Egleston

    Atlanta, Georgia, 30322

    404-785-0910

    Thomas Cash

    Not yet recruiting

  • Childrens Hospital of Alabama

    Birmingham, Alabama, 35233

    Gregory Friedman

    Not yet recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    617-632-5869

    Natalie Collins

    Not yet recruiting

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    312-227-4834

    David Walterhouse

    Recruiting

  • Nationwide Children's Hosp

    Columbus, Ohio, 43205-2664

    614-355-1202

    Mark Ranalli

    Recruiting

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9063

    Theodore Laetsch

    Recruiting

  • Children's Hospital of Colorado

    Denver, Colorado, 80218

    720-777-6740

    Margaret Macy

    Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

    239-343-5437

    Emad Salman

    Recruiting

  • Cook Children's Hospital

    Fort Worth, Texas, 76104-2724

    Active, not recruiting

  • Texas Childrens Hospital

    Houston, Texas, 77025

    832-824-4632

    Jodi Muscal

    Not yet recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    713-745-6754

    Najat Daw

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

    Active, not recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    904-953-2000

    Steven Attia

    Recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    816-302-6808

    Kevin Ginn

    Recruiting

  • Childrens Hospital of Los Angeles

    Los Angeles, California, 90027

    Completed

  • UCLA Medical Center

    Los Angeles, California, 90095

    Noah Federman

    Not yet recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    414-456-4170

    Meghen Browning

    Not yet recruiting

  • University of Minnesota Hospital

    Minneapolis, Minnesota, 55455

    612-626-3593

    Emily Greengard

    Not yet recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    212-639-8856

    Emily Slotkin

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Josephine HaDuong

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Completed

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    602-546-0990

    Alok Kothari

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Alok Kothari

    Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Andrew Bukowinski

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97201

    503-494-4671

    Katrina Winsnes

    Not yet recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02906

    401-829-6552

    Bradley DeNardo

    Recruiting

  • Seattle Children's Hospital Research Foundation

    Seattle, Washington, 98105

    206-987-2114

    Catherine Albert

    Recruiting

  • Washington University Medical School

    St Louis, Missouri, 63110

    Completed

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    202-476-4744

    AeRang Kim

    Recruiting

Other trials in United States

Spain13 sites, 13 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Antonio Lopez Pousa

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Claudia Maria Valverde Morales

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

    Lucas Moreno Martin Retortillo

    Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 8950

    34932532100

    Jaume Mora Graupera

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Rosa Alvarez Alvarez

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Maria Cristina Mata Fernandez

    Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009

    Alba Rubio San Simón

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Andres Redondo Sanchez

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Pedro Rubio

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

    Josefina Cruz Jurado

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Maria Jose Flor Oncala

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    34955012593

    Catalina Marquez-Vega

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Antonio Juan Ribelles

    Recruiting

Other trials in Spain

Italy7 sites, 7 recruiting

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, 40136

    390516366411

    EMANUELA PALMERINI

    Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, 10060

    390119933278

    Massimo Aglietta

    Recruiting

  • Istituto Nazionale dei Tumori

    Milan, 20133

    39022393062

    Andrea Ferrari

    Recruiting

  • Azienda Ospedaliera Di Padova

    Padova, 35128

    Gianni Bisogno

    Recruiting

  • Ospedale Bambino Gesu

    Roma, 00165

    390668592444

    Giuseppe Milano

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168

    Antonio Ruggiero

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Alexia Bertuzzi

    Recruiting

Other trials in Italy

United Kingdom5 sites, 5 recruiting

  • University College Hospital - London

    London, NW1 2PG

    Sandra Strauss

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    Julia Chisholm

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    ROBIN JONES

    Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

    Bernadette Brennan

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Martin McCabe

    Recruiting

Other trials in United Kingdom

France4 sites, 4 recruiting

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

    Bordeaux, 33076

    Antoine Italiano

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    33478785126

    Jean Yves Blay

    Not yet recruiting

  • Centre Leon Berard

    Lyon, 69008

    +33478782642

    Nadege Corradini

    Recruiting

  • Institut Curie

    Paris, 75248

    33144324068

    Sophie Piperno-Neumann

    Not yet recruiting

Other trials in France

Australia3 sites

  • Chris O'Brien Lifehouse

    Camperdown, 2050

    Completed

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Completed

  • Royal Children's Hospital

    Melbourne, 3052

    Completed

Other trials in Australia

Germany3 sites, 3 recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    492017232255

    Uta Dirksen

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Simone Hettmer

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20251

    4940741020622

    Uwe Kordes

    Recruiting

Other trials in Germany

Japan3 sites, 3 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    81120023812

    Chitose Ogawa

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    81120023812

    Yuhki Koga

    Recruiting

  • Hyogo Prefectural Kobe Children's Hospital

    Kobe, 650-0047

    81120023812

    Daiichiro Hasegawa

    Recruiting

Other trials in Japan

Belgium2 sites, 1 recruiting

  • UCL- Saint Luc

    Brussels, 1200

    3227642376

    Benedicte Brichard

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Completed

Other trials in Belgium

Netherlands2 sites, 2 recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

    Hans Gelderblom

    Recruiting

  • Prinses Maxima Centrum

    Utrecht, 3584 CS

    31650006353

    Natasha van Eijkelenburg

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05999994
Study groupRoleWhat they receive
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)ExperimentalRamucirumab 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).
Receives: Drug: Ramucirumab; Drug: Cyclophosphamide; Drug: Vinorelbine
Cyclophosphamide + Vinorelbine (DSRCT ISA)Active comparatorCyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Receives: Drug: Cyclophosphamide; Drug: Vinorelbine
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)ExperimentalRamucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Receives: Drug: Ramucirumab; Drug: Gemcitabine; Drug: Docetaxel
Gemcitabine + Docetaxel (SS ISA)Active comparatorGemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Receives: Drug: Gemcitabine; Drug: Docetaxel
Abemaciclib + Irinotecan + Temozolomide (ES ISA)ExperimentalAbemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Receives: Drug: Abemaciclib; Drug: Irinotecan; Drug: Temozolomide
Irinotecan + Temozolomide (ES ISA)Active comparatorIrinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Receives: Drug: Irinotecan; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Allocated to Each ISA

    Number of Participants Allocated to Each ISA

    Measured: Baseline up to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start22 Jan 2020
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999994
Sponsor's protocol ID
17304
Other IDs
J1S-MC-JAAA
Acronym
CAMPFIRE
Status last verified
Aug 2026
First submitted
14 Aug 2023
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab, Cyclophosphamide and Vinorelbine in people with Neoplasms and Child, run by Eli Lilly and Company at 72 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Spain, Italy, United Kingdom, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Allocated to Each ISA (time frame: Baseline up to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05999994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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