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Checkpoint Inhibitor

Rigosertib + Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment

Phase 1 & 2
Waitlist Available
Led By Rajwanth Veluswamy, MD, MSCR
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, Rigosertib and Nivolumab, in patients with advanced lung cancer who have not responded to earlier treatments. Rigosertib stops cancer cells from growing, and Nivolumab helps the immune system attack the cancer.

Eligible Conditions
  • Lung Cancer
  • Cancer
  • End Stage
  • Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximal Tolerated Dose (MTD)
Overall Response Rate (ORR)
Secondary study objectives
Overall Survival (OS) at MTD
Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rigosertib + NivolumabExperimental Treatment2 Interventions
Rigosertib + Nivolumab in metastatic KRAS+ lung adenocarcinoma patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rigosertib
2020
Completed Phase 2
~30
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Traws Pharma, Inc.Industry Sponsor
32 Previous Clinical Trials
1,705 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
542,135 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,563 Total Patients Enrolled
Onconova Therapeutics, Inc.Industry Sponsor
31 Previous Clinical Trials
1,641 Total Patients Enrolled
Rajwanth Veluswamy, MD, MSCRPrincipal Investigator - Icahn School of Medicine at Mount Sinai
The Mount Sinai Hospital
Medical School - University of Szeged Faculty of Medicine
Methodist Dallas Medical Center, Residency in Internal Medicine

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04263090 — Phase 1 & 2
Cancer Research Study Groups: Rigosertib + Nivolumab
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04263090 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263090 — Phase 1 & 2
~5 spots leftby Dec 2025
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