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Report for Clinical Trial NCT03159117

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Open-Label Dose Escalation of GD3 ADC (Pfizer PF-06688992) in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma (B802WI209568)

The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06688992. Before this study, PF-06688992 has never been given to people. PF-06688992 is a targeted therapy for people with cancer. The investigators linked a chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to GD3 which is found on most melanomas but on very few other cells in the body. The investigators hope that in this way, it will deliver this chemotherapy directly to the melanoma and not to normal tissues.

NCT03159117 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: PF-06688992

Description: (PF-06688992) will be administered on Day 1 of each 21-day cycle per the Dose Preparation and Administration Instructions (DAI) located in the Investigational Product Manual (Appendix 4Appendix 3) as an IV infusion over approximately 60 minutes. A cycle is defined as the time from Day 1 dose to the next Day 1 dose. If there are no treatment delays, a cycle will be 21 days. Each patient may receive PF-06688992 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
Type: Drug
Group Labels: 1

PF 06688992


Primary Outcomes

Description: using a Bayesian dose escalation scheme

Measure: the Recommended Phase 2 Dose

Time: 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

- Patients whose melanomas harbor a BRAF V600E or V600K mutation must have progressed on a RAF inhibitor. --- V600E ---


2 V600K

- Patients whose melanomas harbor a BRAF V600E or V600K mutation must have progressed on a RAF inhibitor. --- V600E --- --- V600K ---



HPO Nodes


HPO: