Trial Outcomes & Findings for Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma (NCT NCT01152788)

Last Updated: 2023-08-22

Results Overview

Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

From randomization to progression or death, up to 22 months

Results posted on

2023-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	rIL-21 rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Overall Study STARTED	32	32
Overall Study COMPLETED	32	28
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	rIL-21 rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Overall Study Withdrawal by Subject	0	3
Overall Study No treatment	0	1

Baseline Characteristics

Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rIL-21 n=32 Participants rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 Participants Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks	Total n=60 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	65 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to progression or death, up to 22 months

Population: treated population

Outcome measures

Outcome measures
Measure	rIL-21 n=32 Participants rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 Participants Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Progression Free Survival	1.87 years Interval 1.74 to 3.45	2.04 years Interval 1.87 to 5.03

SECONDARY outcome

Timeframe: From the start of study treatment until the end of treatment (before disease progression)

Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures \< 10 mm (Note: continue to record the measurement even if \< 10 mm and considered CR). Residual lesions (other than nodes \< 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	rIL-21 n=30 Participants rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 Participants Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Response Rate	13.3 percentage of participants Interval 3.8 to 30.7	14.3 percentage of participants Interval 4.0 to 32.7

SECONDARY outcome

Timeframe: From randomization to death of any cause, up to 22 months

For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.

Outcome measures

Outcome measures
Measure	rIL-21 n=32 Participants rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 Participants Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Overall Survival	6.6 months Interval 5.9 to 12.3	7.3 months Interval 5.0 to 20.3

SECONDARY outcome

Timeframe: Over study period, up to 22 months

To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.

Outcome measures

Outcome measures
Measure	rIL-21 n=32 Participants rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 Participants Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)	17 participants	6 participants

Adverse Events

rIL-21

Serious events: 10 serious events

Other events: 12 other events

Deaths: 0 deaths

Dacarbazine

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rIL-21 n=32 participants at risk rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 participants at risk Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
Hepatobiliary disorders Hepatic failure	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Investigations Aspartate aminotransferase increased	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
General disorders Infusion related reaction	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Cardiac disorders Atrial fibrillation	0.00% 0/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	3.6% 1/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
General disorders Gait disturbance	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Infections and infestations Sepsis	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Gastrointestinal disorders Duodenal obstruction	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Injury, poisoning and procedural complications Fall	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Skin and subcutaneous tissue disorders Other skin and subcutaneous tissue disorders	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Immune system disorders Autoimmune disorder	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Renal and urinary disorders Acute Kidney injury	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Nervous system disorders Ataxia	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Vascular disorders Hypotension	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Investigations Alanine aminotransferase increased	3.1% 1/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.

Other adverse events

Other adverse events
Measure	rIL-21 n=32 participants at risk rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks	Dacarbazine n=28 participants at risk Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
General disorders Fatigue	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	10.7% 3/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Hepatobiliary disorders Hepatic failure	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Skin and subcutaneous tissue disorders Skin and tissue	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
General disorders Chest wall pain	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Metabolism and nutrition disorders Anorexia	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 2/32 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.	0.00% 0/28 • 22 months All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.

Additional Information

Dr. Janet Dancey

NCIC Clinical Trials Group

Phone: 1-613-533-6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place