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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

NCT02719015 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-11-24

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerated dose of rAd.CD40L (also called ISF35) when given with pembrolizumab to patients with melanoma. Researchers also want to learn if the highest tolerated dose of ISF35 and pembrolizumab can help to control the disease.

The safety of this drug combination will be also be studied.

Conditions

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

  • Memgen, LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Adi Diab, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719015 on ClinicalTrials.gov