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
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|ClinicalTrials.gov Identifier: NCT02719015|
Recruitment Status : Withdrawn (No IND Serial #)
First Posted : March 24, 2016
Last Update Posted : November 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: rAd.CD40L Drug: Pembrolizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II 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|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: rAd.CD40L + Pembrolizumab
The dose escalation phase will include rAd.CD40L dose escalation and increase in the number of injected sites/lesions. Once patients tolerate dose level 1 (1 injection site and 1x1011vp-MTD) in Dose Escalation cohort, Expansion cohort will open with same maximum number of injection sites at maximum tolerated dose from Dose Escalation cohort.
All participants receive same dosage of Pembrolizumab in both phases.
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.
Other Name: ISF35
Dose Escalation and Expansion Phases: 2 mg/kg by vein every 3 weeks.
- Maximum Tolerated Dose (MTD) of Intratumoral rAd.CD40L [ Time Frame: 3 weeks ]MTD defined as the dose with the smallest absolute difference between the estimate of pi and the true pT for which Prob (pi > pT | data) is less than 5%.
- Overall Response Rate (ORR) of Intratumoral rAd.CD40L [ Time Frame: 12 weeks ]Tumor response to therapy assessed using immune-related response criteria (irRC), which is a modified version of the World Health Organization (WHO) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719015
|Principal Investigator:||Adi Diab, MD||M.D. Anderson Cancer Center|