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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02714218

Registration number

NCT02714218

Ethics application status

Date submitted

16/03/2016

Date registered

21/03/2016

Date last updated

24/06/2022

Titles & IDs

Public title

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Scientific title

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Secondary ID [1]

CA209-511

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Melanoma

Condition category

Condition code

Cancer

Malignant melanoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - Nivolumab 3 mg/kg IV
Treatment: Other - Ipilimumab 1 mg/kg IV
Treatment: Other - Nivolumab 6 mg/kg IV

Experimental: Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV - Specified dose on specified days

Experimental: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV - Specified dose on specified days

Experimental: Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg - Specified dose on specified days

Treatment: Other: Nivolumab 3 mg/kg IV
Followed by Nivolumab monotherapy

Treatment: Other: Ipilimumab 1 mg/kg IV
Followed by Nivolumab monotherapy

Treatment: Other: Nivolumab 6 mg/kg IV
A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)

Assessment method [1]

The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.

Timepoint [1]

From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)

Secondary outcome [1]

Objective Response Rate (ORR)

Assessment method [1]

The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Timepoint [1]

From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)

Secondary outcome [2]

Overall Survival (OS)

Assessment method [2]

The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates.

Timepoint [2]

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)

Secondary outcome [3]

Progression Free Survival (PFS)

Assessment method [3]

The time between the date of randomization and the first date of documented progression, determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Timepoint [3]

From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)

Secondary outcome [4]

Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale

Assessment method [4]

Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.

Timepoint [4]