Solid TumorPhase 1/2NCT05175235
Nivolumab and Pembrolizumab Dose Optimisation in Solid Tumours With CURATE.AI Platform and Sequential ctDNA Measurements
A Phase 1/2 study testing CURATE.AI and Nivolumab, Pembrolizumab in people with Solid Tumor, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CURATE.AI and Nivolumab, Pembrolizumab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Aug 2021to 1 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Males and females ≥ 21 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Patients must meet the following clinical laboratory criteria within 21 days of starting treatment:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN of ≤ 5 ULN if involvement of the liver.
- Calculated creatinine clearance ≥ 30 mL/min or creatinine < 1.5 x ULN.
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- Main tumour types: Non-small cell lung cancer (NSCLC), gastric cancer (GC), hepatocellular carcinoma (HCC) and nasopharyngeal carcinoma (NPC) or other metastatic solid tumours not for curative intent therapy;
- Treatment with combinational immunotherapy or single-agent nivolumab/pembrolizumab. If patients have already started treatment on this regimen, they may still be eligible to enrol, provided they fulfil all other criteria and approval is sought by PI and Sponsor.
- Eligible for treatment combinational immunotherapy or single-agent nivolumab /pembrolizumab based on co-investigator's assessment of fitness for immunotherapy (e.g. not on high dose corticosteroid therapy or uncontrolled auto-immune disorder)
Who cannot join
- Patients who are lactating or pregnant.
- Patients with clinically significant hypersensitivity to one or more of the selected regimen's constituent drug(s)
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Any clinically significant medical disease or psychiatric condition that, in the co-investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Major surgery within 28 days prior to start of the treatment,
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained.
Trial locations and contacts
1 site in 1 country.
Michelle Au contact
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Cheng Ean Chee, Dr
Wei Peng Yong, Dr
About this study
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.
Read the detailed description
The first stage of the trial aims to identify patients who are responsive to the given treatment, determined from both SOC - radiology via criteria such as RECIST/immune-related RECIST (irRECIST) as well as the intended response marker for CURATE.AI. These patients will then proceed with the second stage of the trial.
The second stage of the trial aims to obtain a personalised CURATE.AI profile for each participant, based on their phenotypic response to a set of drug doses. The doses will be recommended by the CURATE.AI team, when relevant to the clinical decision-making process. For participants who started on the selected therapy prior to their engagement with the study, the previously recorded data, limited to: administered doses, corresponding phenotypic responses and treatment-related toxicities (optional) may be included in the CURATE.AI process. Once an actionable profile is obtained, dose recommendations are based on the profile and aimed to treat the participant.
Since there are no prior clinical trials using CURATE.AI in participant treated with combinational or single-agent immunotherapy with drugs such as nivolumab or pembrolizumab, this trial will comprise of participants diagnosed with the main tumour types: non-small cell lung cancer (NSCLC), gastric cancer (GC), hepatocellular carcinoma (HCC) or nasopharyngeal carcinoma (NPC), or other eligible tumours undergoing or planned for palliative-intent immune-oncology combinational or single-agent therapy with nivolumab/ pembrolizumab.
Nivolumab and Pembrolizumab are an immune checkpoint inhibitors and a novel therapeutic treatment modalities recently approved by the FDA and are becoming the standard of care treatment for a range of oncological indications, including NSCLC, GC, HCC and NPC. However, they are associated with significant semi-annual costs - approximately $140,000 per patient in the United States. In light of the evidence supporting dose personalization and dose reduction in immune-oncology treatments, patients may stand to benefit from CURATE.AI's personalized dose optimisation in maximizing clinical outcomes at reduced costs. Together with the increasing adoption of circulating tumour DNA (ctDNA) as an effective response marker for tumour burden in NSCLC, GC, HCC and NPC, CURATE.AI is ideally suited for pairing these findings with healthcare economics research towards the development of novel healthcare workflows integrating AI and serial measurements of ctDNA response to sustain the scalable implementation of N-of-1 dosing optimisation in cancer treatments.
- Conditions
- Solid Tumor
- Being tested
- CURATE.AI, Nivolumab, Pembrolizumab
- Keywords
- personalized oncology, personalized dose selection, immunotherapy, dose optimisation, Cancer, Artificial Intelligence, CURATE.AI, Nivolumab, Sequential ctDNA, Chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURATE.AIDevice
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.
Nivolumab, PembrolizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CURATE.AI | Experimental | Participants will undergo two treatment periods: selection period and CURATE.AI modulation period. During the selection period, baseline ctDNA measurements and CT scans will be performed. Subsequently, participants will receive Standard of Care (SOC) doses of nivolumab/pembrolizumab and have their ctDNA measured at the end of the third cycle together with other SOC monitoring.
After the first ctDNA measurement and CT scan, selected patients who responded to treatment through both ctDNA and CT scan may continue into the CURATE.AI modulation period. Non-responders will receive SOC doses of nivolumab/pembrolizumab for 2 cycles before having their ctDNA measured and CT scan at the end of the 2 cycles. Subsequent responders through both ctDNA and CT scans may then continue into the CURATE.AI modulation period.
Only the dose of nivolumab/pembrolizumab will be modulated with CURATE.AI, based on measurements of the response marker (ctDNA). Receives: Device: CURATE.AI; Drug: Nivolumab, Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in whom we successfully apply CURATE.AI profile.
CURATE.AI applicability: Percentage of participants in whom we successfully apply CURATE.AI profile. Based on percentages, outcomes will be classified as Green (>70%) / Yellow (10-70%) / Red (<10%).
A decision on whether we "successfully apply" the CURATE.AI profile requires expert judgement and cannot be made based on a purely numerical process. The expert panel will consider the following factors with careful regard for the individual circumstances of each participant:
Error/variance (biological/analytical) is sufficiently small to allow accurate predictions Profile can be generated sufficiently early for the participant to potentially benefit; Dose-dependent relationship is observed; Profile is actionable (i.e. fulfils the clinical investigator's pre-specified safety requirements); Systemic changes in the participant which require profile recalibration are rare or readily assimilated into the CURATE.AI algorithm
Measured: up to 12 months
Secondary outcomes (5)
Patient adherence
Percentage of participants who always adhered to the prescribed dose whenever they took their medication, as measured by the standardised pharmacovigilance protocol. Based on percentages, outcomes will be classified as Green (>90%) / Yellow (10-90%) / Red (<10%).
Measured: Up to 12 months
Timely delivery of CURATE.AI recommendations to the clinician
Percentage of CURATE.AI recommendations provided in time for the next chemotherapy cycle, across all participants and cycles. Based on percentages, outcomes will be classified as Green (100%) / Yellow (10-99%) / Red (<10%).
Measured: Up to 12 months
CURATE.AI relevance
Percentage of dosing events across all participants and cycles in which CURATE.AI recommendation is considered in the clinical decision-making process. Based on percentages, outcomes will be classified as Green (100%) / Yellow (10-99%) / Red (<10%).
Measured: Up to 12 months
Physician adherence
Percentage of CURATE.AI recommended doses that were used by the clinical investigator. Based on percentages, outcomes will be classified as Green (>70%) / Yellow (10-70%) / Red (<10%).
Measured: Up to 12 months
Clinically significant dose changes
Percentage of participants in whom the CURATE.AI-guided cumulative dose is substantially (≥10%) different from the projected standard-of-care cumulative dose. Based on percentages, outcomes will be classified as Green (>20%) / Yellow (1-20%) / Red (0%).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start19 Aug 2021
- Primary completion31 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-centre, one-arm, prospective pilot study of participants diagnosed with solid tumours. The participants will be enrolled for the duration of their treatment with Nivolumab. At 12-month mark, the decision on the patient engagement with the study will be made by the principal investigator in consultation with the study sponsors and treating physician.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- The N.1 Institute for Health (N.1), Natera, Inc.
- Responsible party
- Sponsor
- Investigators
- Raghav Sundar, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175235
- Sponsor's protocol ID
- 2020/00334-Immunotherapy
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin JC, Wang WY, Chen KY, Wei YH, Liang WM, Jan JS, Jiang RS. Quantification of plasma Epstein-Barr virus DNA in patients with advanced nasopharyngeal carcinoma. N Engl J Med. 2004 Jun 10;350(24):2461-70. doi: 10.1056/NEJMoa032260.
PubMed 15190138Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M, Keegan P, Pazdur R. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. Oncologist. 2016 May;21(5):634-42. doi: 10.1634/theoncologist.2015-0507. Epub 2016 Mar 16.
PubMed 26984449Evan TH, Jenny Z, Eun-Jeong K, Grace H, Shailender B, Sunil AR. Economic analysis of alternative pembrolizumab and nivolumab dosing strategies at an academic cancer centre. JCO 2019; 37(15): 6504-6504. doi: 10.1200/JCO.2019.37.15_suppl.6504
Yoo SH, Keam B, Kim M, Kim SH, Kim YJ, Kim TM, Kim DW, Lee JS, Heo DS. Low-dose nivolumab can be effective in non-small cell lung cancer: alternative option for financial toxicity. ESMO Open. 2018 Jul 25;3(5):e000332. doi: 10.1136/esmoopen-2018-000332. eCollection 2018.
PubMed 30094065Low JL, Huang Y, Sooi K, Ang Y, Chan ZY, Spencer K, Jeyasekharan AD, Sundar R, Goh BC, Soo R, Yong WP. Low-dose pembrolizumab in the treatment of advanced non-small cell lung cancer. Int J Cancer. 2021 Jul 1;149(1):169-176. doi: 10.1002/ijc.33534. Epub 2021 Mar 6.
PubMed 33634869
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab and Pembrolizumab Dose Optimisation in Solid Tumours With CURATE.AI Platform and Sequential ctDNA Measurements
- ClinicalTrials.gov ID
- NCT05175235
- Acronym / sponsor ID
- 2020/00334-Immunotherapy
- Conditions
- Solid Tumor
- Keywords
- personalized oncology, personalized dose selection, immunotherapy, dose optimisation, Cancer, Artificial Intelligence, CURATE.AI, Nivolumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- The N.1 Institute for Health (N.1), Natera, Inc.
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first stage of the trial aims to identify patients who are responsive to the given treatment, determined from both SOC - radiology via criteria such as RECIST/immune-related RECIST (irRECIST) as well as the intended response marker for CURATE.AI. These patients will then proceed with the second stage of the trial.
The second stage of the trial aims to obtain a personalised CURATE.AI profile for each participant, based on their phenotypic response to a set of drug doses. The doses will be recommended by the CURATE.AI team, when relevant to the clinical decision-making process. For participants who started on the selected therapy prior to their engagement with the study, the previously recorded data, limited to: administered doses, corresponding phenotypic responses and treatment-related toxicities (optional) may be included in the CURATE.AI process. Once an actionable profile is obtained, dose recommendations are based on the profile and aimed to treat the participant.
Since there are no prior clinical trials using CURATE.AI in participant treated with combinational or single-agent immunotherapy with drugs such as nivolumab or pembrolizumab, this trial will comprise of participants diagnosed with the main tumour types: non-small cell lung cancer (NSCLC), gastric cancer (GC), hepatocellular carcinoma (HCC) or nasopharyngeal carcinoma (NPC), or other eligible tumours undergoing or planned for palliative-intent immune-oncology combinational or single-agent therapy with nivolumab/ pembrolizumab.
Nivolumab and Pembrolizumab are an immune checkpoint inhibitors and a novel therapeutic treatment modalities recently approved by the FDA and are becoming the standard of care treatment for a range of oncological indications, including NSCLC, GC, HCC and NPC. However, they are associated with significant semi-annual costs - approximately $140,000 per patient in the United States. In light of the evidence supporting dose personalization and dose reduction in immune-oncology treatments, patients may stand to benefit from CURATE.AI's personalized dose optimisation in maximizing clinical outcomes at reduced costs. Together with the increasing adoption of circulating tumour DNA (ctDNA) as an effective response marker for tumour burden in NSCLC, GC, HCC and NPC, CURATE.AI is ideally suited for pairing these findings with healthcare economics research towards the development of novel healthcare workflows integrating AI and serial measurements of ctDNA response to sustain the scalable implementation of N-of-1 dosing optimisation in cancer treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-centre, one-arm, prospective pilot study of participants diagnosed with solid tumours. The participants will be enrolled for the duration of their treatment with Nivolumab. At 12-month mark, the decision on the patient engagement with the study will be made by the principal investigator in consultation with the study sponsors and treating physician.
| Arm | Type | Receives |
|---|---|---|
| CURATE.AI | Experimental | Device: CURATE.AI, Drug: Nivolumab, PembrolizumabParticipants will undergo two treatment periods: selection period and CURATE.AI modulation period. During the selection period, baseline ctDNA measurements and CT scans will be performed. Subsequently, participants will receive Standard of Care (SOC) doses of nivolumab/pembrolizumab and have their ctDNA measured at the end of the third cycle together with other SOC monitoring. After the first ctDNA measurement and CT scan, selected patients who responded to treatment through both ctDNA and CT scan may continue into the CURATE.AI modulation period. Non-responders will receive SOC doses of nivolumab/pembrolizumab for 2 cycles before having their ctDNA measured and CT scan at the end of the 2 cycles. Subsequent responders through both ctDNA and CT scans may then continue into the CURATE.AI modulation period. Only the dose of nivolumab/pembrolizumab will be modulated with CURATE.AI, based on measurements of the response marker (ctDNA). |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females ≥ 21 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Patients must meet the following clinical laboratory criteria within 21 days of starting treatment:
- Main tumour types: Non-small cell lung cancer (NSCLC), gastric cancer (GC), hepatocellular carcinoma (HCC) and nasopharyngeal carcinoma (NPC) or other metastatic solid tumours not for curative intent therapy;
- Treatment with combinational immunotherapy or single-agent nivolumab/pembrolizumab. If patients have already started treatment on this regimen, they may still be eligible to enrol, provided they fulfil all other criteria and approval is sought by PI and Sponsor.
Key exclusion criteria (6 listed)
- Patients who are lactating or pregnant.
- Patients with clinically significant hypersensitivity to one or more of the selected regimen's constituent drug(s)
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Any clinically significant medical disease or psychiatric condition that, in the co-investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Major surgery within 28 days prior to start of the treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CURATE.AIEfficacy 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. | Device | CURATE.AI |
| Nivolumab, PembrolizumabTreatment 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. | Drug | CURATE.AI |
Primary outcome
Percentage of participants in whom we successfully apply CURATE.AI profile.
Time frame: up to 12 months
CURATE.AI applicability: Percentage of participants in whom we successfully apply CURATE.AI profile. Based on percentages, outcomes will be classified as Green (>70%) / Yellow (10-70%) / Red (<10%). A decision on whether we "successfully apply" the CURATE.AI profile requires expert judgement and cannot be made based on a purely numerical process. The expert panel will consider the following factors with careful regard for the individual circumstances of each participant: Error/variance (biological/analytical) is sufficiently small to allow accurate predictions Profile can be generated sufficiently early for the participant to potentially benefit; Dose-dependent relationship is observed; Profile is actionable (i.e. fulfils the clinical investigator's pre-specified safety requirements); Systemic changes in the participant which require profile recalibration are rare or readily assimilated into the CURATE.AI algorithm
5 secondary outcomes
Patient adherence
Time frame: Up to 12 months
Timely delivery of CURATE.AI recommendations to the clinician
Time frame: Up to 12 months
CURATE.AI relevance
Time frame: Up to 12 months
Physician adherence
Time frame: Up to 12 months
Clinically significant dose changes
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 15190138Lin JC, Wang WY, Chen KY, Wei YH, Liang WM, Jan JS, Jiang RS. Quantification of plasma Epstein-Barr virus DNA in patients with advanced nasopharyngeal carcinoma. N Engl J Med. 2004 Jun 10;350(24):2461-70. doi: 10.1056/NEJMoa032260.
- Results publication: PubMed 26984449Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M, Keegan P, Pazdur R. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. Oncologist. 2016 May;21(5):634-42. doi: 10.1634/theoncologist.2015-0507. Epub 2016 Mar 16.
- Results publicationEvan TH, Jenny Z, Eun-Jeong K, Grace H, Shailender B, Sunil AR. Economic analysis of alternative pembrolizumab and nivolumab dosing strategies at an academic cancer centre. JCO 2019; 37(15): 6504-6504. doi: 10.1200/JCO.2019.37.15_suppl.6504
- Results publication: PubMed 30094065Yoo SH, Keam B, Kim M, Kim SH, Kim YJ, Kim TM, Kim DW, Lee JS, Heo DS. Low-dose nivolumab can be effective in non-small cell lung cancer: alternative option for financial toxicity. ESMO Open. 2018 Jul 25;3(5):e000332. doi: 10.1136/esmoopen-2018-000332. eCollection 2018.
- Results publication: PubMed 33634869Low JL, Huang Y, Sooi K, Ang Y, Chan ZY, Spencer K, Jeyasekharan AD, Sundar R, Goh BC, Soo R, Yong WP. Low-dose pembrolizumab in the treatment of advanced non-small cell lung cancer. Int J Cancer. 2021 Jul 1;149(1):169-176. doi: 10.1002/ijc.33534. Epub 2021 Mar 6.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Au contact
Raghav Sundar principal investigator
NUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CURATE.AI and Nivolumab, Pembrolizumab in people with Solid Tumor, 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raghav Sundar (+65 6779 5555, raghav_sundar@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants in whom we successfully apply CURATE.AI profile. (time frame: up to 12 months). 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 NCT05175235, which also lists 5 linked publications.
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 3 Mar 2023.