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Carcinoma, HepatocellularPhase 2VALUE-CHECKNCT06422403

A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers

A Phase 2 study testing Extended Dosing Interval - A, Extended Dosing Interval - B and Extended Dosing Interval - C in people with Carcinoma, Hepatocellular and Gastric Adenocarcinoma, run by National University Hospital, Singapore at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%… Read more about this study

Who is it for?
Ages 21 to 99 years
What is being tested?
Extended Dosing Interval - A, Extended Dosing Interval - B and Extended Dosing Interval - C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteSingapore
Study dates
25 Nov 2024to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
  • Unstable spinal cord compression/brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.
  • Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.
  • Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
  • Autoimmune disorders
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  • Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
  • Previous allogeneic bone marrow transplant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Peng Yong contact

+65 6908 2222

Wei_Peng_YONG@nuhs.edu.sg

Singapore1 site, 1 recruiting

  • Department of Hematology-Oncology, National University Hospita

    Singapore

    Wei Peng Yong, +65 6908 2222, Wei_Peng_YONG@nuhs.edu.sg

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the detailed description

This study aims to assess the noninferiority of progression free survival of standard dosing compared to extended dosing interval of nivolumab, pembrolizumab and atezolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma, and non-small cell lung cancer with PDL1 TPS≥50%.

Secondary Objective

  • To investigate the safety, overall survival (OS) of ICI at extended dosing interval of the standard versus extended dosing interval groups.
  • To investigate the pharmacokinetics (PK) of nivolumab, atezolizumab or pembrolizumab.
Being tested
Extended Dosing Interval - A, Extended Dosing Interval - B, Extended Dosing Interval - C, Standard of Care - A, Standard of Care - B
Keywords
Nivolumab, Atezolizumab, Pembrolizumab, Extended dosing interval
Medical subject headings
Carcinoma, Hepatocellular, Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Dosing Interval - ADrug

    Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX

  • Extended Dosing Interval - BDrug

    Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years)

  • Extended Dosing Interval - CDrug

    Pembrolizumab 200mg 6 weekly (up to 2 years)

  • Standard of Care - ADrug

    Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX

  • Standard of Care - BDrug

    Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years)

  • Standard of Care - CDrug

    Pembrolizumab 200mg 3 weekly (up to 2 years)

Study groups in NCT06422403
Study groupRoleWhat they receive
Cohort A (SOC)Active comparatorNivolumab, XELOX/FOLFOX
Receives: Drug: Standard of Care - A
Cohort A (EDI)ExperimentalNivolumab, XELOX/FOLFOX
Receives: Drug: Extended Dosing Interval - A
Cohort B (SOC)Active comparatorBevacizumab, Atezolizumab
Receives: Drug: Standard of Care - B
Cohort B (EDI)ExperimentalBevacizumab, Atezolizumab
Receives: Drug: Extended Dosing Interval - B
Cohort C (SOC)Active comparatorPembrolizumab
Receives: Drug: Standard of Care - C
Cohort C (EDI)ExperimentalPembrolizumab
Receives: Drug: Extended Dosing Interval - C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the time from date of first dosing until the date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1) or death (by any cause in the absence of progression).

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Number of participant with treatment related haematological and non-haematological toxicities

    As defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: Up to 2 years

  2. Objective response rate

    Percentage of patients who have at least one confirmed response of 'complete response' or 'partial response' as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1), that is confirmed at least 4 weeks later

    Measured: Up to 2 years

  3. Duration of Response

    Duration of response will be defined as the time from the date of first documented response, that is subsequently confirmed until the date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.

    Measured: Up to 2 years

  4. Disease control rate

    Disease control rate is defined as the proportion of patients with a best overall response of CR = complete response, PR = partial response, or SD = stable disease, as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1)

    Measured: Up to 2 years

  5. Overall survival

    Overall survival will be assessed based on the date of first dose and survival status at the time of analysis.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start25 Nov 2024
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a prospective, open label, multi-centre phase 2 trial
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422403
Sponsor's protocol ID
2024-3881
Acronym
VALUE-CHECK
Status last verified
Jul 2024
First submitted
15 May 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Extended Dosing Interval - A, Extended Dosing Interval - B and Extended Dosing Interval - C in people with Carcinoma, Hepatocellular and Gastric Adenocarcinoma, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Peng Yong (+65 6908 2222, Wei_Peng_YONG@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06422403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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