Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorcept Therapeutics
About this trial
This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated institutional review board (IRB)/ independent ethics committee (IEC)-approved informed consent form (ICF)
Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment
Has a life expectancy of ≥ 3 months
Has evaluable disease based on RECIST v1.1
Disqualifiers
Grade ≥ 3
Resulted in discontinuation of anti-PD(L)1 therapy
Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy
Medical history of adrenal insufficiency
Trial design
Design model
Sequential
Treatments tested in this trial
Nenocorilant 200 mg
DrugNenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 300 mg
DrugNenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 400 mg
DrugNenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
Nivolumab
DrugNivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Cohort 1a: Nenocorilant 200 mg and NivolumabExperimental treatment 2 interventions
Group B: Cohort 1b: Nenocorilant 300 mg and NivolumabExperimental treatment 2 interventions
Group C: Cohort 1c: Nenocorilant 400 mg and NivolumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Patients With 1 or More Adverse Event
Time frame
From first dose of study treatment up to 28 days after final dose, assessed up to 9 months2
Number of Patients With 1 or More Serious Adverse Events
Time frame
From first dose of study treatment up to 28 days after final dose, assessed up to 9 months3
Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation
Time frame
From first dose of study treatment up to final dose, assessed up to 9 months4
Percent of Patients who Experience Dose Limiting Toxicity (DLT)
Time frame
Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)Secondary outcomes
1
Objective Response Rate (ORR)
To evaluate the proportion of patients with measurable disease at baseline who attain a confirmed complete response (CR) or partial response (PR).
Time frame
From date of first dose to progressive disease (PD)/confirmed PD using immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iCPD) or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months2
Duration of Response (DoR)
To evaluate DoR as the time from the first CR or PR to first documented PD/iCPD or death or start of non-protocol-specified new anticancer therapy, whichever occurs first.
Time frame
Time of first objective response until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months3
Best Overall Response (BOR)
To evaluate BOR as the proportion of patients with a BOR of CR, PR, stable disease (SD), PD, or nonevaluable.
Time frame
From first dose until PD/iCPD or death or start of non-protocol-specified anticancer therapy, assessed up to 8 months4
Duration of SD
To evaluate duration of SD as defined as the time from the start of combination treatment until the criteria for PD/iCPD are met.
Time frame
Date of start of combined treatment until the criteria for PD/iCPD are met, assessed up to 8 monthsSponsors and contacts
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Source ClinicalTrials.gov