Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2018

Primary Completion Date

March 31, 2022

Study Completion Date

March 31, 2022

Conditions
Melanoma
Interventions
DRUG

rAd.CD40L

"Dose Escalation Phase Starting Dose: 5x10\^10 vp per tumor as an injection directly into 1-3 tumors every 3 weeks. Same tumors injected for each of the 4 injections at week 0, 3, 6 and 9. If the dose well tolerated, the rAd.CD40L escalated to 1x10\^11 vp. Subsequently enrolled patients injected at the same dose of 1x10\^11 vp. Number of injected sites/tumors increased to two sites/lesions if patients have \>/=2 injectable lesions, at the same injection dose of 1x10\^10 up to three separate sites/lesions if patients have \> 3 injectable lesions.~Dose Expansion Phase Starting Dose: MTD from Dose Escalation Phase."

DRUG

Pembrolizumab

Dose Escalation and Expansion Phases: 2 mg/kg by vein every 3 weeks.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Memgen, LLC

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT02719015 - Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma | Biotech Hunter | Biotech Hunter