Locally Advanced Unresectable or Metastatic MelanomaPhase 2NCT04768881
Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
A Phase 2 study testing Selinexor and Pembrolizumab in people with Locally Advanced Unresectable or Metastatic Melanoma, run by Karyopharm Therapeutics Inc at 13 sites in United States.
Trial summary
Approximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Melanoma
- What is being tested?
- Selinexor and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 13 sitesUnited States
- Study dates
- 12 May 2021to 22 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to (≥) 18 years at the time of informed consent.
- Participant must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
- Participants must have confirmed PD per Response Evaluation Criteria in Solid Tumors (RECIST) on or within 12 weeks of the last dose of anti-PD-1/L1 monotherapy or combination therapy (including relatlimab or other anti-LAG-3 mAb) per Society for Immunotherapy in Cancer Guidelines (Kluger,2020).
- Arm A (primary resistance): participant has disease progression after receiving at least 6 weeks of prior anti-PD-1/L1 mAb with the best response as PD, or stable disease (SD) less than (<) 6 month (participants with a partial response [PR] or complete response [CR] who have disease progression within 6 months will be considered to have primary resistance in this study).
- Arm B (secondary/acquired resistance): participant has disease progression after receiving at least 6 months of prior anti-PD-1/L1 mAb with the best response as CR, PR, or SD greater than (>) 6 months (participants who have disease progression after neoadjuvant or adjuvant therapy, will be considered to have secondary resistance in this study).
- Participants who progress on or within 12 weeks after elective discontinuation of anti-PD-1/L1 mono or combination treatment in the absence of PD or treatment limiting toxicity must have confirmed PD per RECIST.
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- Participants should have at least 1 prior line of CPI therapy but no more than 2.
- Measurable disease according to RECIST v1.1.
- Participants with stable previously treated brain metastases are permitted in this study.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (≤) 1.
- Adequate bone marrow function at screening, defined as:
- Absolute neutrophil count (ANC) ≥1.5 * 10^9 per liter (L).
- Hemoglobin ≥10 gram per deciliter (gm/dL) (≥6.2 millimoles per liter [mmol/L]).
- Platelet count ≥100 * 10^9/L.
- Serum direct bilirubin ≤1.5 * upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 * ULN (with confirmed liver metastases: AST and ALT ≤5 * ULN).
- Calculated creatinine clearance (CrCl) ≥15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Childbearing potential excludes: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy.
- Male participants who are sexually active must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male participants must agree not to donate sperm during the study treatment period.
- Written informed consent signed in accordance with federal, local, and institutional guidelines.
Who cannot join
- Metastatic uveal or ocular melanoma.
- Active central nervous system (CNS) metastases or other CNS (e.g., meningeal) involvement.
- Participants must have resolution or improvement of immune-mediated treatment related adverse reactions related to prior treatment(s) to Grade ≤1 without steroid maintenance therapy or his or her previous baseline prior to the corresponding CPI therapy
- History of immune-mediated treatment related adverse reactions leading to discontinuation of prior anti-programmed death protein 1 (PD-1), anti-programmed death protein ligand 1 (PD-L1), or anti programmed death protein ligand 2 (PD-L2) monoclonal antibodies (mAbs) or severe hypersensitivity reaction to any mAb or any excipients which in the opinion of the Investigator precludes future use of anti-PD-1/PDL1 therapy.
- Concurrent systemic steroid therapy higher than physiologic dose (>10 milligrams per day [mg/day] of prednisone or equivalent).
- Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors.
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- Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:
- Not recovered from major surgery ≤28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted.
- Have ongoing clinically significant anti-cancer therapy-related toxicities Common Terminology Criteria for Adverse Events (CTCAE) Grade >1. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor
- Had last dose of previous anti-cancer therapy ≤14 days prior to Day 1 dosing
- Palliative radiotherapy >14 days prior to the study is allowed
- Received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug (whichever is shorter), prior to Cycle 1 Day 1 (C1D1).
- Live-attenuated vaccine (e.g., nasal spray influenza vaccine) ≤14 days prior to the intended C1D1.
- Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting, or diarrhea that is CTCAE version 5.0 grade >1).
- Life expectancy less than (<) 4 months based on the opinion of the Investigator
- Active pneumonitis requiring steroid therapy.
- Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, prevent the participant from giving informed consent, or being compliant with the study procedures.
- Female participants who are pregnant or lactating.
- Active hepatitis B virus treated with antiviral therapy for hepatitis B within 8 weeks with a viral load >100 international units per milliliter (IU/mL).
- Untreated hepatitis C virus positive without documentation of negative viral load per institutional standard.
- Human immunodeficiency virus positive with CD4+T-cells ≤350 cells per microliter, positive viral load per institutional standard, and a history of acquired immunodeficiency syndrome defining opportunist infections in the last year.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
New York Oncology Hematology
Albany, New York, 12206
Texas Oncology-Austin Central
Austin, Texas, 78731
OH Care Clinical Trials
Cincinnati, Ohio, 45242
Cleveland Clinic Foundation
Cleveland, Ohio, 44144
Texas Oncology - Baylor Sammons Center
Dallas, Texas, 75246
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
UCLA
Los Angeles, California, 90095
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Great Plains Health
North Platte, Nebraska, 69101
TOI Clinical Research
Pasadena, California, 91105
BRCR Global
Plantation, Florida, 33322
About this study
Official title: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
Approximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Participants who have disease progression (PD) after discontinuation of CPIs, especially in neoadjuvant or adjuvant therapy, will be considered to have acquired resistance in this study. Participants will receive study treatment (Selinexor and Pembrolizumab) until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.
- Being tested
- Selinexor, Pembrolizumab
- Keywords
- Karyopharm, Locally advanced unresectable or metastatic melanoma, KPT-330, Recurrent advanced melanoma, Selinexor, Pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called KPT-330, XPOVIO®
Dose and formulation: 80 mg (4 tablets of 20 mg)
PembrolizumabDrug
Also called KEYTRUDA®
Dose and formulation: 400 mg (25 milligrams per milliliter [mg/mL]) Solution
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Primary resistance to Initial CPI Therapy | Experimental | 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. Receives: Drug: Selinexor; Drug: Pembrolizumab |
| Arm B: Acquired Resistance to Initial CPI Therapy | Experimental | 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. Receives: Drug: Selinexor; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) Assessed as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). ORR was assessed by RECIST 1.1 as defined by the Investigator based on radiologic criteria. Per RECIST 1.1 criteria, CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than (<)10 millimeter (mm). PR was defined as at least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of randomization until the documentation of CR or PR, whichever occurs first (up to 24 months)
Secondary outcomes (10)
Progression-free Survival (PFS) as Per RECIST v 1.1
PFS was defined as time from date of first treatment to the date of first confirmed progressive disease (PD), assessed by RECIST 1.1 is objectively documented or death due to any cause. As per RECIST 1.1 criteria, PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Measured: From the date of randomization until disease progression or death, due to any cause (up to 24 months)
Overall Survival (OS)
OS was defined as the time from date of first study treatment until death due to any cause. If death event did not occur during the follow-up period, the participant was censored at the date of discontinuation from the study (i.e. withdrawal of consent), or date of last participating visit (e.g., a telephone contact with participant status being alive) on or before database cutoff date, whichever occurs first.
Measured: From the date of first study treatment up to death (up to 24 months)
Complete Response Rate (CRR)
Complete response rate was defined as percentage of participants who had achieved a complete response (CR) per RECIST 1.1. As per RECIST version 1.1, CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduced in the short axis to <10 mm.
Measured: Up to 101 weeks
Duration of Response (DOR) as Per RECIST v 1.1
DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. Per RECIST 1.1 criteria, CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Measured: From first occurrence of CR or PR until disease progression or death, whichever occurs first (up to 24 months)
Percentage of Participants With Disease Control Rate (DCR) as Per RECIST v 1.1
Disease control rate was defined as percentage of participants who have a response of CR, PR, or at least 12 continuous weeks of stable disease (SD) as per RECIST v 1.1. As per RECIST v 1.1 before PD or initiating a new antineoplastic therapy, CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study. Percentage values were rounded off.
Measured: Up to 24 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE was defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
Measured: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Clinical laboratory parameters included clinical chemistry, hematology and urinalysis. Number of participants with clinically significant laboratory abnormalities which were deemed clinically significant by the investigator were reported.
Measured: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included body temperature, blood pressure (systolic blood pressure and diastolic blood pressure). Measurements were made after the participant had been resting supine for a minimum of 5 minutes. The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in vital signs values were reported.
Measured: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Changes in Physical Examination
Number of participants with clinically significant physical examination abnormalities including general appearance, dermatological, head, eyes, ears, nose, throat, respiratory, cardiovascular, abdominal, lymph nodes, musculoskeletal, and neurological examinations. Number of participants with clinically significant physical examination abnormalities which were deemed clinically significant by the investigator were reported.
Measured: From start of the study treatment up to 24 months
Number of Participants With Severity of Adverse Events Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
AEs are graded using the following criteria using Common Terminology Criteria for Adverse events v5.0: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE.
Measured: From start of the study treatment up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start12 May 2021
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Why it stopped: The trial was terminated due to a lack of sufficient anti-melanoma tumor signal for the combination of selinexor + pembrolizumab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Unresectable or Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karyopharm Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768881
- Sponsor's protocol ID
- XPORT-MEL-033
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2021
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
- ClinicalTrials.gov ID
- NCT04768881
- Acronym / sponsor ID
- XPORT-MEL-033
- Keywords
- Karyopharm, Locally advanced unresectable or metastatic melanoma, KPT-330, Recurrent advanced melanoma, Selinexor, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated due to a lack of sufficient anti-melanoma tumor signal for the combination of selinexor + pembrolizumab.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karyopharm Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Participants who have disease progression (PD) after discontinuation of CPIs, especially in neoadjuvant or adjuvant therapy, will be considered to have acquired resistance in this study. Participants will receive study treatment (Selinexor and Pembrolizumab) until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Primary resistance to Initial CPI Therapy | Experimental | Drug: Selinexor, Drug: PembrolizumabParticipants 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. |
| Arm B: Acquired Resistance to Initial CPI Therapy | Experimental | Drug: Selinexor, Drug: PembrolizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age greater than or equal to (≥) 18 years at the time of informed consent.
- Participant must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
- Participants should have at least 1 prior line of CPI therapy but no more than 2.
- Measurable disease according to RECIST v1.1.
- Participants with stable previously treated brain metastases are permitted in this study.
Key exclusion criteria (22 listed)
- Metastatic uveal or ocular melanoma.
- Active central nervous system (CNS) metastases or other CNS (e.g., meningeal) involvement.
- Participants must have resolution or improvement of immune-mediated treatment related adverse reactions related to prior treatment(s) to Grade ≤1 without steroid maintenance therapy or his or her previous baseline prior to the corresponding CPI therapy
- Concurrent systemic steroid therapy higher than physiologic dose (>10 milligrams per day [mg/day] of prednisone or equivalent).
- Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorAlso: KPT-330, XPOVIO®Dose and formulation: 80 mg (4 tablets of 20 mg) | Drug | Arm A: Primary resistance to Initial CPI Therapy, Arm B: Acquired Resistance to Initial CPI Therapy |
| PembrolizumabAlso: KEYTRUDA®Dose and formulation: 400 mg (25 milligrams per milliliter [mg/mL]) Solution | Drug | Arm A: Primary resistance to Initial CPI Therapy, Arm B: Acquired Resistance to Initial CPI Therapy |
Primary outcome
Overall Response Rate (ORR) Assessed as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: From the date of randomization until the documentation of CR or PR, whichever occurs first (up to 24 months)
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). ORR was assessed by RECIST 1.1 as defined by the Investigator based on radiologic criteria. Per RECIST 1.1 criteria, CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than (<)10 millimeter (mm). PR was defined as at least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
10 secondary outcomes
Progression-free Survival (PFS) as Per RECIST v 1.1
Time frame: From the date of randomization until disease progression or death, due to any cause (up to 24 months)
Overall Survival (OS)
Time frame: From the date of first study treatment up to death (up to 24 months)
Complete Response Rate (CRR)
Time frame: Up to 101 weeks
Duration of Response (DOR) as Per RECIST v 1.1
Time frame: From first occurrence of CR or PR until disease progression or death, whichever occurs first (up to 24 months)
Percentage of Participants With Disease Control Rate (DCR) as Per RECIST v 1.1
Time frame: Up to 24 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Time frame: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From start of the study treatment up to 24 months
Number of Participants With Clinically Significant Changes in Physical Examination
Time frame: From start of the study treatment up to 24 months
Number of Participants With Severity of Adverse Events Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: From start of the study treatment up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor and Pembrolizumab in people with Locally Advanced Unresectable or Metastatic Melanoma, run by Karyopharm Therapeutics Inc at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) Assessed as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: From the date of randomization until the documentation of CR or PR, whichever occurs first (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.