Evidence map›Paper›PMID 39945382›Full record

ArticleCancer medicine2025

A Phase IB Trial of Selinexor in Combination With Immune Checkpoint Blockade in Patients With Advanced Renal Cell Carcinoma.

Omar Alhalabi, Mohamed A Gouda, Denái R Milton, Hassan Ahmed Momin, Bulent Yilmaz, Bettzy Stephen, Chinenye Lynette Ejezie, Justin Tyler Moyers, Serdar A Gurses, Jeffrey How and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02419495 (Phase IB Study to Evaluate the Safety of Selinexor), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02419495 phase1terminatednot on this map

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2015 to 2024Enrolled221ConditionsAdvanced Malignant Solid Neoplasm, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Fallopian Tube CarcinomaArmsCapecitabine, Carboplatin, Cyclophosphamide, Doxorubicin, Eribulin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Digital oncology interventions and equity: a scoping review of design strategies to address cancer disparities.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Article
  3. Review
  4. Selinexor in Uveal Melanoma: A Hopeful Step or Just Another Hurdle?Journal of immunotherapy and precision oncology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Omar AlhalabiDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9658-2206
Mohamed A GoudaDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0003-4829-6739
Denái R MiltonDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hassan Ahmed MominDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Bulent YilmazDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Bettzy StephenDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0003-1653-2012
Chinenye Lynette EjezieDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-7335-8597
Justin Tyler MoyersThe Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, California, USA.
Serdar A GursesDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jeffrey HowDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Siqing FuDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-1933-0419
Jordi RodonDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
David S HongDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sarina A Piha-PaulDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Vivek SubbiahDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-6064-6837
Ecaterina Elena DumbravaDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Daniel D KarpDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Filip JankuDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Funda Meric-BernstamDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Nizar M TannirDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Aung NaingDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-4803-8513

Funding

Karyopharm TherapeuticsNCI NIH HHS GrantP30CA016672
6 · The paper itself

Abstract

backgroundSelinexor (SEL) is a nuclear exportin 1 inhibitor that blocks the transport of nuclear proteins, including tumor suppressors, to the cytoplasm. Preclinical data suggest that the combination of SEL with checkpoint blockade may result in improved response to immunotherapy.

methodsNCT02419495 was a multiarm phase IB study of SEL in combination with other standard regimens in patients with advanced malignancies. Arm M utilized twice weekly oral SEL and intravenous nivolumab (NIVO). Arm N utilized weekly oral SEL with NIVO plus ipilimumab (IPI). The primary objective of this study was to evaluate the safety of SEL + NIVO and SEL + NIVO+IPI. Secondary objectives included determining the objective response rate (ORR) and progression-free survival (PFS).

resultsTwenty-nine patients were enrolled in the study, of which 26 (90%) had clear cell RCC (ccRCC). Most patients (72%, n = 21) had prior systemic therapies. All patients (100%) developed at least one treatment-emergent adverse event, and 93% had a treatment-related adverse event (TRAE). Grade ≥ 3 TRAE occurred in 31% of patients, including 10% with hyponatremia, 7% with neutropenia, and 7% with thromboembolic events. At a median follow-up of 12.4 months, the ORR in 27 patients evaluable for response was 19% (n = 5). An additional 17 patients (63%) had stable disease (SD) as the best response. The median PFS for the overall cohort was 14.5 months (95% CI 5.2-17.4 months; SEL + NIVO+IPI: 12.2 months, SEL + NIVO: 14.5 months). The median overall survival was 27.8 months (95% CI 15.3-32.5; SEL + NIVO+IPI: unreached, SEL + NIVO: 21.3 months).

conclusionsSEL in combination with NIVO or NIVO+IPI had a potentially favorable safety profile and showed modest clinical activity in patients with advanced renal cell carcinoma.

trial registrationThis clinical trial was registered on clinicaltrials.gov (NCT02419495).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellHydrazinesImmune Checkpoint InhibitorsKidney NeoplasmsTriazolesAdultAgedAged, 80 and overFemaleHumansIpilimumabMaleMiddle AgedNivolumabProgression-Free SurvivalHydrazinesImmune Checkpoint InhibitorsIpilimumabNivolumabselinexorTriazolesimmunotherapyrenal cell carcinomaselinexor

Identifiers

PMID39945382
PMCPMC11822648

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.