Trial Outcomes & Findings for CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma (NCT NCT04145700)

Last Updated: 2023-09-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)

Results posted on

2023-09-13

Participant Flow

Completers included participants who died from any cause.

Participant milestones

Participant milestones
Measure	Ramucirumab + Gemcitabine + Docetaxel 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.	Gemcitabine + Docetaxel 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.
Overall Study STARTED	16	7
Overall Study Received at Least One Dose of Study Drug	16	6
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ramucirumab + Gemcitabine + Docetaxel 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.	Gemcitabine + Docetaxel 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.
Overall Study Withdrawal by Subject	8	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramucirumab + Gemcitabine + Docetaxel n=16 Participants 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.	Gemcitabine + Docetaxel n=7 Participants 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.	Total n=23 Participants Total of all reporting groups
Age, Continuous	17.70 years STANDARD_DEVIATION 4.22 • n=5 Participants	21.40 years STANDARD_DEVIATION 4.58 • n=7 Participants	18.80 years STANDARD_DEVIATION 4.58 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Italy	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)

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

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=16 Participants 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.	Gemcitabine + Docetaxel n=7 Participants 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.
Progression Free Survival (PFS)	2.10 Months Interval 2.0 to 6.0	2.03 Months Interval 1.38 to There were not enough events to estimate the upper confidence limit.

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up To 6.4 Months)

Population: All randomized participants.

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.

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=16 Participants 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.	Gemcitabine + Docetaxel n=7 Participants 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.
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)	6.3 Percentage of participants Interval 0.7 to 22.2	0 Percentage of participants Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=1 Participants 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.	Gemcitabine + Docetaxel 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.
Duration of Response (DoR)	NA Months DoR couldn't be calculated as the participant did not achieve the event and was censored.	—

SECONDARY outcome

Timeframe: Baseline Up to 6.94 months

Population: All randomized participants.

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

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=16 Participants 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.	Gemcitabine + Docetaxel n=7 Participants 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.
Complete Response (CR): Percentage of Participants Who Achieve CR	0 Percentage of participants Interval 0.0 to 13.4	0 Percentage of participants Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1

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

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.

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=10 Participants 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.	Gemcitabine + Docetaxel 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.
Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)	231 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 43	—

SECONDARY outcome

Timeframe: Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5

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

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.

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=10 Participants 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.	Gemcitabine + Docetaxel 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.
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 8 of Cycle 1	73.3 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 39	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 2	55.4 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 24	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 5	NA microgram per milliliter (µg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 32.4 µg/mL, 41.3 µg/mL	—

SECONDARY outcome

Timeframe: Baseline Up to 6.94 months

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

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).

Outcome measures

Outcome measures
Measure	Ramucirumab + Gemcitabine + Docetaxel n=7 Participants 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.	Gemcitabine + Docetaxel n=1 Participants 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.
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)	0 Participants	0 Participants

Adverse Events

Ramucirumab + Gemcitabine + Docetaxel

Serious events: 8 serious events

Other events: 15 other events

Deaths: 8 deaths

Gemcitabine + Docetaxel

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Ramucirumab + Gemcitabine + Docetaxel n=16 participants at risk 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.	Gemcitabine + Docetaxel n=6 participants at risk 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/16 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Mallory-weiss syndrome	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
General disorders Pyrexia	12.5% 2/16 • Number of events 3 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Immune system disorders Anaphylactic reaction	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/16 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Infections and infestations Sepsis	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Investigations Platelet count decreased	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/16 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	16.7% 1/6 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	12.5% 2/16 • Number of events 2 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.
Vascular disorders Embolism	6.2% 1/16 • Number of events 1 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.	0.00% 0/6 • Baseline Up to 6.94 months All randomized participants who received at least one dose of study drug.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60