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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Child; Neoplasms; Adolescent

Treatments: Drug: Docetaxel; Drug: Ramucirumab; Drug: Abemaciclib; Drug: Cyclophosphamide; Drug: Irinotecan; Drug: Vinorelbine; Drug: Temozolomide; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05999994

J1S-MC-JAAA (Other Identifier)

17304

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 1 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 6 patient groups

Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)

Experimental group

Description:

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).

Treatment:

Drug: Vinorelbine

Drug: Cyclophosphamide

Drug: Ramucirumab

Cyclophosphamide + Vinorelbine (DSRCT ISA)

Active Comparator group

Description:

Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.

Treatment:

Drug: Vinorelbine

Drug: Cyclophosphamide

Ramucirumab + Gemcitabine + Docetaxel (SS ISA)

Experimental group

Description:

Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.

Treatment:

Drug: Gemcitabine

Drug: Ramucirumab

Drug: Docetaxel

Gemcitabine + Docetaxel (SS ISA)

Active Comparator group

Description:

Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.

Treatment:

Drug: Gemcitabine

Drug: Docetaxel

Abemaciclib + Irinotecan + Temozolomide (ES ISA)

Experimental group

Description:

Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.

Treatment:

Drug: Temozolomide

Drug: Irinotecan

Drug: Abemaciclib

Irinotecan + Temozolomide (ES ISA)

Active Comparator group

Description:

Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.

Treatment:

Drug: Temozolomide

Drug: Irinotecan