A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: f
View:

• Provision of informed consent prior to any study-specific procedure

• Patients with one of the following:

‣ Cohort A: Previously untreated locally advanced/metastatic HER2 -ve gastric/gastroesophageal junction/esophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab.

⁃ Cohort B: Previously untreated locally advanced/metastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab.

⁃ Cohort C: Previously untreated locally advanced/metastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR/ALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy

• Measurable disease per RECIST 1.1 criteria

• ECOG Performance status is 0-2

• Normal organ and bone marrow function measured within 28 days before the study as defined below:

‣ Haemoglobin ≥ 8.0 g/dL and no blood transfusions in the 28 days prior to entry

⁃ Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L

⁃ No features suggestive of MDS/AML on peripheral blood smear

⁃ White blood cells (WBC) \> 3x10\^9/L

⁃ Platelet count ≥ 100 x 10\^9/L

⁃ Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)

⁃ AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN

⁃ Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)

• A life expectancy ≥ 12 weeks in all patients.

• Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:

• The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments

• Women \<50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.

⁃ Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio

⁃ Male patients should be willing to use barrier contraception

⁃ The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.

⁃ At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements

Locations
Other Locations
Singapore
Department of Hematology-Oncology, National University Hospita
RECRUITING
Singapore
Contact Information
Primary
Wei Peng Yong
Wei_Peng_YONG@nuhs.edu.sg
+65 6908 2222
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 360
Treatments
Active_comparator: Cohort A (SOC)
Nivolumab, XELOX/FOLFOX
Experimental: Cohort A (EDI)
Nivolumab, XELOX/FOLFOX
Active_comparator: Cohort B (SOC)
Bevacizumab, Atezolizumab
Experimental: Cohort B (EDI)
Bevacizumab, Atezolizumab
Active_comparator: Cohort C (SOC)
Pembrolizumab
Experimental: Cohort C (EDI)
Pembrolizumab
Sponsors
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov

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