MedTrace Logo

Nivolumab and Pembrolizumab Dose Optimisation in Solid Tumours With CURATE.AI Platform and Sequential ctDNA Measurements

NCT05175235 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-03

No results posted yet for this study

Summary

CURATE.AI - a small data, AI-derived technology platform - allows personalised guidance of an individual's dose modulations based only on that individual's data. Additionally, CURATE.AI is mechanism-independent, and dynamically adapts to changes experienced by the subject, providing dynamic dose optimisation throughout the duration of the subject's treatment. This study aims to demonstrate the feasibility of applying CURATE.AI in standard of care settings for treatment of solid tumours with Nivolumab. An additional objective is to explore sequential ctDNA measurements as a response marker collected at a higher frequency of probing, with modulated doses.

Conditions

Interventions

DEVICE

CURATE.AI

Efficacy and toxicity measurements at the end of each two-/three- week dosing cycle, together with an information on given drugs and their doses, and other patient data, will be used by CURATE.AI to recommend the dose of nivolumab/pembrolizumab for the next cycle. The clinical investigators will decide whether or not to administer or prescribe the dose recommendation from CURATE.AI.

DRUG

Nivolumab, Pembrolizumab

Treatment with the selected regimen will take up to a maximum duration of 12 months, in two-/three- week cycles. CURATE.AI dose recommendations will be generated before each chemotherapy cycle; fixed throughout the cycle; Maximum total cumulative dose per cycle of nNivolumab/pembrolizumab in the predetermined safety range is set at 100% of standard starting dose (i.e. , 240 mg/m2 once every 2 weeks for single agent Nivolumab and 200 mg/m2 once every 3 weeks for single agent Pembrolizumab). Minimum total cumulative dose per cycle of nivolumab/pembrolizumab in the predetermined safety range is set at 30% of the standard starting dose (i.e. 8072 mg/m2 once every 2 weeks for single agent Nivolumab and 60 mg/m2 once every 3 weeks for single agent Pembrolizumab). Subject-specific dosing range may alter those numbers to suit the specific circumstances of the subject, thus giving the subject specific safe dosing range.

Sponsors & Collaborators

  • The N.1 Institute for Health (N.1)

    collaborator OTHER

  • Natera, Inc.

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Raghav Sundar · NUH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2023-05-31
Completion
2023-08-01

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175235 on ClinicalTrials.gov