Clinical trial NCT06956248: Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
Official title: Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Keywords: Advanced Cancers
Solid Tumours
Off-label Cancer Therapies
Non-standard Cancer Therapies
Molecular Tumour Board (MTB)
Response Assessment
Real-World Data Collection
Precision Oncology
Translational Research
Patient Reported Outcomes (PROs)
Quality of Life (QOL)
Treatment Outcomes
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: SingHealth Duke-NUS Academic Medical Centre
First posted: 2025-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologic or cytologic confirmation confirmed of advanced refractory solid tumours with no further suitable treatment options.

Brief summary: This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board.

1. To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations.

   - Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations.
2. To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study.

   * Through standard safety laboratory investigations (FBC, U/E/Cr, LFT)
   * Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months.

Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development

Detailed description: The patient will be observed clinically after informed consent has been obtained. Patients may require more frequent assessment or additional procedures as clinically necessary or as required by the product label.

* Each participant will have undergone comprehensive molecular profiling with results discussed at NCCS molecular tumour board. Where necessary, orthogonal studies/assays may be performed.
* The molecular profiling results will be provided by the referring physician and primary investigator/co-investigator (PI/Co-I). All cases will be presented in the NCCS Molecular Tumour Board (MTB) where there is an adequate quorum of participating members.
* The MTB will analyse the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions.
* The subsequent treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.
* Translational tissue and plasma may be additionally collected at various timepoints during the study for correlational translational research

Eligibility criteria: Inclusion Criteria:

1. Is equal to or greater than 21 years of age;
2. Histologic or cytologic confirmed advanced solid tumours;
3. Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
4. Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

1. Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
2. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol.

Primary outcomes:
measure: Best objective response rate at 12 weeks
timeFrame: Up to 12 weeks.
measure: Tumour growth rate inhibition
timeFrame: Up to 12 weeks.
Secondary outcomes:
measure: Incidence of adverse events (AEs), Identified and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.
timeFrame: From the initiation of protocol therapy, up to 30 days after last dose of off-label or non-standard therapy.
measure: Quality of life thorough AE evaluation or equivalent instruments such as the EORTC QLQ-C30 questionnaire.
timeFrame: Baseline and after every 2 cycles till end of treatment, up to 2 years.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References: