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A master protocol for testing cancer drugs in children and young adults

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

Phase 2 Interventional Eli Lilly and Company · NCT05999994

This study is trying out different cancer drugs to see how well they work for children and young adults with cancer, using a flexible approach that allows for new treatments to be added as they become available.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment105 (estimated)
Ages1 Year to 39 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations73 sites (Birmingham, Alabama and 72 other locations)
Trial IDNCT05999994 on ClinicalTrials.gov

What this trial studies

This master protocol aims to streamline the execution of multiple clinical trials for children and young adults with cancer by providing a unified research framework. It allows for the testing of various drugs, including Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, and Docetaxel, under specific research goals tailored to different cancer types. New studies can be incorporated as new treatments become available, enhancing the efficiency of cancer research. Participants will be enrolled based on their eligibility and the duration of benefit from the treatments.

Who should consider this trial

Good fit: Ideal candidates include children and young adults with measurable or evaluable cancer who meet specific performance and health criteria.

Not a fit: Patients who are currently undergoing cancer treatment or have not recovered from significant side effects may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment options for pediatric cancer patients.

How similar studies have performed: Other studies utilizing master protocols have shown promise in improving the efficiency of clinical trials, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NeoplasmsChildAdolescent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.