This research study is being done to learn more about relapsed/refractory multiple myeloma, and if the study drug GSK2857916 given in combination with pembrolizumab can improve your relapsed/refractory multiple myeloma or make you feel better.
We also would like to answer the following questions:
Pembrolizumab, to be given with GSK2857916 in this study, is approved to treat patients with various types of cancer. It is not approved for the treatment of the type of cancer like the kind you have, but it is being studied to see how well it works in many types of cancer.
Two studies, KEYNOTE-183 and KEYNOTE-185, looked at study participants with the same type of cancer you have, but with other study drugs combined with pembrolizumab. The other study drugs were types of drugs called immunomodulatory agents (pomalidomide [KEYNOTE-183] or lenalidomide [KEYNOTE-185]) plus dexamethasone (a type of steroid). These drugs work by adjusting the immune response in your body.
In both studies, control groups were used to compare against the pembrolizumab combination. The control group was made up of study participants who received lenalidomide or pomalidomide plus dexamethasone, without pembrolizumab. The Food and Drug Administration (FDA) was allowed to see results obtained during those studies, and before the study officially ended. The results showed an increased risk of death for study participants in the group receiving pembrolizumab with these other study drugs. For KEYNOTE-183, the estimated risk of death was 1.6 times more than the control arm (without pembrolizumab). For KEYNOTE-185, the estimated risk of death was doubled (2 times more than the control arm).
If you have any questions about these studies, you can discuss them with your study doctor.
This current study will combine pembrolizumab with GSK2857916, which is not similar to the drugs combined with pembrolizumab in the studies that were stopped by the FDA. There is a chance that by adding pembrolizumab to GSK2857916, there may be an increase in toxicity (bad effects) by combining these drugs.
The study will be conducted in two parts.
In Part 1, about 12 people in approximately 4 countries may be in the study. Part 1 of the study will look at how people react to and how the body uses GSK2857916 at different doses when taken with pembrolizumab.
We also want to know how the combination of the 2 study drugs affects your cancer and how the body handles the drugs when GSK2857916 and pembrolizumab are given together, and whether these two study drugs affect each other in the body. We will give study participants different doses of GSK2857916. The effects of the study drugs, both good and bad, will be studied.
Approximately 2 dose levels of GSK2857916 will be tested. At least 3 study participants will receive GSK2857916 at each dose level before a decision is made to give the next dose level. Side effects and lab results will be reviewed to be sure that the dose is safe before making the decision about the next dose to be given. Neither you nor the study doctor can choose which dose you will be assigned to.
After the best dose of GSK2857916 is determined in Part 1, about 28 people in approximately 4 countries may enroll in Part 2 of the study. Part 2 of the study will start in different study participants than in Part 1 to test the effects of the best dose of GSK2857916 (identified in Part 1) plus pembrolizumab in a larger group of study participants with relapsed/refractory multiple myeloma. The study doctor will explain to you in which Part, Part 1 or Part 2, you will be participating.
The study drugs are planned to be given once every 3 weeks on Day 1 of each 21 day cycle. GSK2857916 will be given at different dose levels (2.5 mg/kg or 3.4 mg/kg) as an IV infusion into a vein, followed by a 1-hour rest. Then pembrolizumab will be given as an IV infusion of 200mg. If you have an infusion-related reaction to GSK2857916, your dose of pembrolizumab may be delayed or skipped. If there is any need to delay or skip your dose of GSK2857916, your dose of pembrolizumab will not be administered until your next dose of GSK2857916. Your study doctor will tell you how long these infusions will last.
You may be in the study as long as you are receiving benefit without side effects that you can’t tolerate from taking GSK2857916 plus pembrolizumab, for a maximum of 35 cycles (about 2 years). Your participation in the study will end if you have reached the maximum 35 cycles, have disease progression (your multiple myeloma gets worse) or decide to stop participating in the study.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
You may be eligible to participate in this study if you:
The following criteria is provided for health care professionals.
A subject will NOT be eligible for inclusion in this study if any of the following criteria apply:
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
This trial has active trial locations in countries outside of the United States.
Our system currently only provides clinical trial matching services for myeloma patients in the United States.
You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.
GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.