Combination Therapy With GEN0101 and Pembrolizmub in Advanced Melanoma Patients PIb/PII

Description

1. Primary Objective & Hypothesis
   1. Objective: Efficacy of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy. When the last subject completes Week 13 (Day 85th), the RECIST v1.1-based antitumor effect is assessed for all the subjects up to Week 17 (Day 113th) and then the ORR is calculated in both treatment groups, which are tested to examine the significant difference to historical data of KEYNOTE-002.
   2. Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced.
   3. Secondary Objectives & Hypothesises
   4. Objectives: Efficacy and safety of the combination therapy The combination therapy with intracutaneous injections of GEN0101 + intravenous infusions of Pembrolizumab is given to patients with confirmed SD or unconfirmed PD after anti-PD-1 antibody therapy.

When the last subject completed Week 17 (Day 113th), antitumor effect in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) is assessed based on RECIST v1.1, irRC, and irRECIST for all subjects and then the ORR is calculated. Likewise, changes in individual tumor sizes in Week 13 (Day 85th, unconfirmed) and Week 17 (Day 113th, confirmed) are measured, and then percent changes in tumor sizes (percent tumor shrinkage or growth) are calculated. In each subject, the induction of antitumor immunity in Week 13 (Day 85th) is investigated with the index of activated NK cells in peripheral blood.

When the last subject completed Week 53 (Day 365th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002.

When the last subject completed Week 105 (Day 729th), antitumor effect is assessed for all the subjects based on OS and RECIST v1.1, irRC, and irRECIST-based ORR, BOR and PFS, which are tested to examine significant difference to historical data of KEYNOTE-002.

On the basis of these results, the antitumor effect and the induction of antitumor immunity of the combination therapy is investigated. These are secondary objectives in the trial.

As another secondary objective, AEs are investigated in all the subjects for safety evaluation of the combination therapy until the last subject completed Week 105 (Day 729th).

2. Hypothesis: The antitumor effect and the induction of antitumor immunity of the combination therapy would be enhanced and the safety would be acceptable.

3. Exploratory Objective Objective: Storage and use of samples for future exploratory evaluation

Details