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Checkpoint Inhibitor
Selinexor + Pembrolizumab for Melanoma
Phase 2
Waitlist Available
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new combination therapy for people with melanoma who have either primary or acquired resistance to checkpoint inhibitor therapy.
Who is the study for?
Adults over 18 with advanced melanoma that's not treatable by surgery and has worsened after immunotherapy can join. They should have tried at most two prior therapies, have measurable disease, stable brain metastases if any, good performance status, and agree to contraception. Excluded are those with eye melanoma, active brain involvement or infections needing strong antibiotics recently.Check my eligibility
What is being tested?
The trial is testing Selinexor combined with Pembrolizumab in patients who either initially resisted or later developed resistance to checkpoint inhibitor therapy for advanced melanoma. Participants will continue treatment until disease progression, unacceptable side effects occur or they choose to leave the study.See study design
What are the potential side effects?
Selinexor and Pembrolizumab may cause fatigue, nausea, decreased appetite, blood count changes increasing infection risk; also potential for lung inflammation (pneumonitis), liver issues and infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Complete Response Rate (CRR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Acquired Resistance to Initial CPI TherapyExperimental Treatment2 Interventions
Participants will receive a dose of 80 mg selinexor orally once weekly (QW) and a dose of pembrolizumab 400 mg IV Q6W, both on Day 1 of a 6-week cycle until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.
Group II: Arm A: Primary resistance to Initial CPI TherapyExperimental Treatment2 Interventions
Participants will receive a dose of 80 milligrams (mg) selinexor orally once weekly (QW) and a dose of pembrolizumab 400 mg intravenously (IV) once in every six weeks (Q6W), both on Day 1 of a 6-week cycle until progressive disease (PD), intolerable toxicity or withdrawal from the study, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,539 Total Patients Enrolled
1 Trials studying Melanoma
8 Patients Enrolled for Melanoma
Reshma Rangwala, MD, PhDStudy DirectorKaryopharm Therapeutics Inc
2 Previous Clinical Trials
521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have melanoma that has spread to other parts of the body or originates in the eye.You have active cancer that has spread to your brain or other parts of your central nervous system.You must have had improvement of side effects from previous treatments to a mild level or better without needing to take steroids regularly.You have hepatitis C and have not received treatment, or do not have proof that your viral load is negative according to the hospital's rules.You have active hepatitis B and are currently being treated for it. Your viral load is higher than 100 IU/mL.You have ongoing lung inflammation that needs to be treated with steroids.You have a severe infection that is not under control and requires strong antibiotics, antivirals, or antifungals.You have been diagnosed with advanced melanoma that cannot be removed with surgery.You have shown disease progression within 12 weeks after receiving a certain type of cancer treatment.You have HIV with a low number of certain immune cells, high viral load, and a history of serious infections related to AIDS in the past year.You have been treated with selinexor or other medications that work like selinexor.You have a stomach or intestine problem that might affect how your body absorbs selinexor.You are taking more than 10 milligrams per day of prednisone or a similar medication.The doctor thinks you may have less than 4 months to live.You have received at least one but no more than two previous treatments with CPI therapy.You have a measurable disease as defined by RECIST v1.1.You can join the study if you have had brain metastases that were treated and are now stable.You are in good enough health to perform daily activities without help.Your bone marrow is working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Acquired Resistance to Initial CPI Therapy
- Group 2: Arm A: Primary resistance to Initial CPI Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Pembrolizumab present any notable adverse effects?
"Considering that Pembrolizumab is only in Phase 2, our team at Power assessed its safety to be a score of 2. This indicates some data supporting the drug's safe use but no evidence for effectiveness yet."
Answered by AI
What additional evidence is available surrounding the efficacy of Pembrolizumab?
"Since its initial investigation by City of Hope in 2010, pembrolizumab has been the subject of 280 completed studies. Additionally, 1005 active clinical trials are being conducted around Dallas and California."
Answered by AI
What common medical issues does Pembrolizumab typically address?
"Pembrolizumab can be employed to treat malignant tumours, unresectable melanoma and cancers with a high microsatellite instability."
Answered by AI
Are there opportunities for individuals to partake in this experiment?
"As per the clinicaltrials.gov website, recruitment for this medical study is still ongoing. It was initially published on May 12th 2021 and its latest update took place November 15th 2022."
Answered by AI
What is the current intake capacity for this clinical research?
"That is correct. The clinical trial was initially posted on May 12th 2021, and the most recent update occurred November 15th 2022. This research seeks 40 participants to be enrolled across 13 separate sites."
Answered by AI
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