Pfizer PF-06688992 in Patients With Stage III or Stage IV Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03159117|
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : May 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: PF-06688992||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a Phase 1 non-randomized, open-label, single-center, single-arm multiple dose escalation|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: PF 06688992
This clinical study will be a dose-finding phase I study in which patients will be treated with various doses of Pfizer PF-06688992 using a Bayesian dose escalation scheme.
(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
Other Name: GD3 ADC
- the Recommended Phase 2 Dose [ Time Frame: 1 year ]using a Bayesian dose escalation scheme
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): NCT03159117
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul Chapman, MD||Memorial Sloan Kettering Cancer Center|