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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04263090
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rigosertib — DRUG
    Rigosertib will be dosed twice a day for 21 consecutive days, followed by 7 days off treatment (each cycle duration: 28 days). Rigosertib escalation will occur with three dose levels (dose D1: 280mg twice daily; dose D2: 560mg qAM, 280mg qPM; dose D3: 560mg twice daily).
  • Nivolumab — DRUG
    Nivolumab will be dosed once ever 2 weeks (twice per 28-day cycle; standard fixed dose of 240mg).

Study Details

A Phase1/2a Study of Rigosertib plus Nivolumab in Stage IV Lung Adenocarcinoma Patients with KRAS Mutation who Progressed on First-Line Treatment

Key Dates

Start date
Jun 29, 2020
Status verified
May 2024
Primary completion
Dec 20, 2023
Completion
Dec 20, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rigosertib + Nivolumab
    Rigosertib + Nivolumab in metastatic KRAS+ lung adenocarcinoma patients

Primary Outcome Measure

Maximal Tolerated Dose (MTD) [ Time Frame: DLTs will be evaluated at the end of Cycle 1 (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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