Symptoms and General Pathology

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Sarcoma

Desmoplastic Small Round Cell Tumor

Neoplasms, Connective and Soft Tissue

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Soft Tissue Sarcoma

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Vinorelbine

Cyclophosphamide

Ramucirumab

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Alkylating Agents

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Angiogenesis Inhibitors

Growth Inhibitors

Ramucirumab given intravenously (IV), Cyclophosphamide given orally and vinorelbine given IV.

Cyclophosphamide given orally and vinorelbine given IV.

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This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

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.

Number of Participants with Anti-Ramucirumab Antibodies

Eli Lilly and Company

Skin and Connective Tissue Diseases

Sarcoma, Synovial

Neoplasms, Connective Tissue

Synovial Sarcoma

Gemcitabine

Docetaxel

Antimetabolites

Participants received intravenous (IV) infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma

A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma

PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later.

ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.

CR is a disappearance of all target and non-target lesions and normalization of tumor marker level.

Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics.

Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.

A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20 (treatment-induced).

All randomized participants who received at least one dose of study drug.

Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

Ramucirumab + Gemcitabine + Docetaxel

Gemcitabine + Docetaxel

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Australia

Italy

Spain

United Kingdom

United States

Region of Enrollment

The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR \< 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.

Chief Medical Officer

To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.

All randomized participants (including the censored participants). Number of participants censored in Ramucirumab + Gemcitabine + Docetaxel=4, Gemcitabine + Docetaxel=2.

Progression Free Survival (PFS)

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

All randomized participants who had CR or PR responses. For Gemcitabine + Docetaxel, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.

Duration of Response (DoR)

Complete Response (CR): Percentage of Participants Who Achieve CR

All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.

Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

Day 8 of Cycle 1

Day 1 of Cycle 2

Day 1 of Cycle 5

PK: Minimum Serum Concentration of Ramucirumab (Cmin)

All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.

Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)

Participants received intravenous infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor	NCT04145349	Desmoplastic Sm...	Ramucirumab Cyclophosphamid... Vinorelbine	12 Months - 29 Years	Eli Lilly and Company
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor	NCT04145349	Desmoplastic Sm...	Ramucirumab Cyclophosphamid... Vinorelbine	12 Months - 29 Years	Eli Lilly and Company
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma	NCT04145700	Synovial Sarcom...	Ramucirumab Gemcitabine Docetaxel	12 Months - 29 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for adolescents and young adults (ayas)