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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05999994

Collaborator

(none)

105

Enrollment

Location

Arms

75.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Child Adolescent	Drug: Ramucirumab Drug: Cyclophosphamide Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Abemaciclib Drug: Irinotecan Drug: Temozolomide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 22, 2020

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

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: Ramucirumab Administered IV Other Names: LY3009806 Drug: Gemcitabine Administered IV Other Names: LY188011 Drug: Docetaxel Administered IV
Active Comparator: Gemcitabine + Docetaxel (SS ISA) Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.	Drug: Gemcitabine Administered IV Other Names: LY188011 Drug: Docetaxel Administered IV
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: Abemaciclib Administered orally Other Names: LY2835219 Drug: Irinotecan Administered IV Drug: Temozolomide Administered orally
Active Comparator: Irinotecan + Temozolomide (ES ISA) Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.	Drug: Irinotecan Administered IV Drug: Temozolomide Administered orally

Outcome Measures

Primary Outcome Measures

Number of Participants Allocated to Each ISA [Baseline up to Week 4]
Number of Participants Allocated to Each ISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.