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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms, Child, Adolescent

Intervention / Treatment
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* Drug: Ramucirumab
* Drug: Cyclophosphamide
* Drug: Vinorelbine
* Drug: Gemcitabine
* Drug: Docetaxel
* Drug: Abemaciclib
* Drug: Irinotecan
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)<br>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<br>* Administered IV<br>* Other names: LY3009806;Drug: Cyclophosphamide<br>* Administered orally<br>Drug: Vinorelbine<br>* Administered IV<br>|
| Active Comparator: Cyclophosphamide + Vinorelbine (DSRCT ISA)<br>Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. | Drug: Cyclophosphamide<br>* Administered orally<br>Drug: Vinorelbine<br>* Administered IV<br>|
| Experimental: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)<br>Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. | Drug: Ramucirumab<br>* Administered IV<br>* Other names: LY3009806;Drug: Gemcitabine<br>* Administered IV<br>* Other names: LY188011;Drug: Docetaxel<br>* Administered IV<br>|
| Active Comparator: Gemcitabine + Docetaxel (SS ISA)<br>Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. | Drug: Gemcitabine<br>* Administered IV<br>* Other names: LY188011;Drug: Docetaxel<br>* Administered IV<br>|
| Experimental: Abemaciclib + Irinotecan + Temozolomide (ES ISA)<br>Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;Drug: Irinotecan<br>* Administered IV<br>Drug: Temozolomide<br>* Administered orally<br>|
| Active Comparator: Irinotecan + Temozolomide (ES ISA)<br>Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA. | Drug: Irinotecan<br>* Administered IV<br>Drug: Temozolomide<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

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