APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT02706353|
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : April 9, 2018
You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma.
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma.
The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma.
The safety of this drug combination will also be studied.
This is an investigational study. APX005M is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. The combination of these drugs to treat metastatic melanoma is investigational.
The study doctor can explain how the study drug is designed to work.
Up to 41 participants will be treated in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: APX005M Drug: Pembrolizumab||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 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 CD40 Agonistic Monoclonal Antibody APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma|
|Actual Study Start Date :||June 2, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: APX005M + Pembrolizumab
Dose Escalation Phase:
Starting dose level of APX005M is 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses. Tumor site chosen based on volume to be injected.
All participants receive Pembrolizumab at 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M.
Dose Expansion Phase:
Starting dose level of APX005M is maximum tolerated dose from Dose Escalation Phase.
Participants receive same dosage of Pembrolizumab as in Dose Escalation Phase.
Dose Escalation Phase Starting Dose Level of APX005M: 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses.
Dose Expansion Phase Starting Dose Level of APX005M: Maximum tolerated dose from Dose Escalation Phase.
Dose Escalation and Expansion Phase Dose of Pembrolizumab: 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M.
- Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma - Dose Escalation Phase [ Time Frame: 3 weeks ]MTD defined as the highest dose for which the posterior probability of toxicity is closes to 30%, among all the tried doses i for which Pr (δ i > 0.30 | data) < 0.95. Toxicities graded according to the National Cancer Institute Common Terminology Criteria (CTC) for Adverse Events version 4.03.
- Overall Response Rate (ORR) After Intratumoral Injection of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma - Dose Expansion Phase [ 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.
- Immune-Related Best Overall Response (irBOR) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma [ Time Frame: 12 weeks ]
irBOR is the best confirmed immune-related response criteria (irRC) overall response over the study as a whole, recorded between the date of first dose until the last tumor assessment.
Correlation between change in cluster of differentiation 8 (CD8+) T-cell density of injected lesion and tumor shrinkage of non-injected lesion conducted based on Pearson's correlation coefficient and Spearman's rank correlation coefficient.
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): NCT02706353
|Contact: Adi Diab, MD||713-792-2921||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Adi Diab, MD||M.D. Anderson Cancer Center|