Colorectal CancerPhase 1/2CheckMate 9N9NCT03377361
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
A Phase 1/2 study testing Nivolumab, Trametinib and Ipilimumab in people with Colorectal Cancer and Colorectal Tumors, run by Bristol-Myers Squibb at 47 sites in 10 countries.
Trial summary
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Tumors, Colorectal Carcinoma
- What is being tested?
- Nivolumab, Trametinib and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 47 sitesin 10 countries
- Study dates
- 31 Jan 2018to 4 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
- Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
- Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Who cannot join
- BRAF V600 mutant colorectal cancer
- Active brain metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- History of interstitial lung disease or pneumonitis
- Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
- History of allergy or hypersensitivity to study drug components
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
47 sites in 10 countries.
47 sites in 10 countries
United States16 sites
Local Institution - 0028
Baltimore, Maryland, 21287
Local Institution - 0022
Birmingham, Alabama, 35249
Local Institution - 0029
Charlotte, North Carolina, 28204
Local Institution - 0107
Gainesville, Florida, 32610
Local Institution - 0116
Hattiesburg, Mississippi, 39401-7233
Local Institution - 0100
Lancaster, Pennsylvania, 17604
Local Institution - 0027
Los Angeles, California, 90033
Local Institution - 0067
Los Angeles, California, 90089
Local Institution - 0002
Madison, Wisconsin, 53792-0001
Local Institution - 0111
Miami, Florida, 33136
Local Institution - 0104
New York, New York, 10016
Local Institution - 0003
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Local Institution - 0001
San Francisco, California, 94158
Local Institution - 0103
St Louis, Missouri, 63110
Local Institution - 0101
Temple, Texas, 76508
Spain7 sites
Local Institution - 0079
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0052
Barcelona, 08035
Local Institution - 0114
Madrid, 28007
Local Institution - 0051
Madrid, 28041
Local Institution - 0115
Madrid, 28050
Local Institution - 0080
Pamplona, Navarre, 31009
Local Institution - 0096
Seville, 41013
Australia5 sites
Local Institution - 0044
Blacktown, New South Wales, 2148
Local Institution - 0055
Clayton, Victoria, 0
Local Institution - 0068
Elizabeth Vale, South Australia, 05112
Local Institution - 0069
Heidelberg, Victoria, 3084
Local Institution - 0043
Southport, Queensland, 4215
Argentina4 sites
Local Institution - 0123
Buenos Aires, Distrito Federal, 1181
Local Institution - 0122
Buenos Aires, Distrito Federal, C1096AAS
Local Institution - 0119
Buenos Aires, 1431
Local Institution - 0120
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Canada4 sites
Local Institution - 0113
Edmonton, Alberta, T6G 1Z2
Local Institution - 0077
Montreal, Quebec, H2X 0A9
Local Institution - 0076
Ottawa, K1H 8L6
Local Institution - 0070
Toronto, Ontario, M5G 2M9
Italy4 sites
Local Institution - 0095
Catania, 95124
Local Institution - 0093
Milan, 20133
Local Institution - 0092
Padova, 35128
Local Institution - 0094
Rozzano, 20089
Czechia3 sites
Local Institution - 0071
Brno, 65653
Local Institution - 0073
Hradec Králové, 500 05
Local Institution - 0072
Olomouc, Olomouc Region, 779 00
Chile2 sites
Local Institution - 0117
Santiago, Santiago Metropolitan, 000000
Local Institution - 0118
Santiago, Santiago Metropolitan, 8420383
About this study
Official title: A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
- Being tested
- Nivolumab, Trametinib, Ipilimumab, Regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
TrametinibDrug
Also called Mekinist
Specified dose on specified days
IpilimumabBiological
Also called Yervoy, BMS-734016
Specified dose on specified days
RegorafenibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Trametinib |
| Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Trametinib; Biological: Ipilimumab |
| Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Trametinib; Biological: Ipilimumab |
| Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Trametinib; Biological: Ipilimumab |
| Part 2 Cohort 5 (3L): Regorafenib | Experimental | Not described Receives: Drug: Regorafenib |
| Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Trametinib; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities in Part 1 and Part 1A
Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.
Measured: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen
Safety Related Events in Part 1 and Part 1 A
Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests
Number of participants with clinical laboratory abnormalities in specific thyroid tests
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests
Number of participants with clinical laboratory abnormalities in specific liver tests.
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Overal Response Rate in Part 1B and Part 2
ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).
Measured: Approximately up to 30 Months
Secondary outcomes (9)
Objective Response Rate in Part 1 and Part 1A
ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).
Measured: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Disease Control Rate in Part 1 and Part 1A
The disease control rate (DCR) is defined as the percentage of participants whose BOR is either confirmed CR or confirmed PR or stable disease (SD)
Measured: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Duration of Response in Part 1 and Part 1A
DOR for a participant with a BOR of confirmed CR or PR, is defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST 1.1 or death, whichever occurs first.
Measured: Approximately up to 20 Months
Time to Response in Part 1 and Part 1A
Time to response (TTR) is defined for participants who had a confirmed CR or PR as the time from the first dosing date to the date of first documented CR or PR per RECIST 1.1.
Measured: From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)
Progression Free Survival in Part 1 and Part 1A
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression per RECIST 1.1 (ie, radiologic) or death due to any cause, whichever occurs first.
Measured: from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)
Overall Survival in Part 1 and Part 1A
OS for a participant is defined as the time from the first dosing date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.
Measured: Approximately up to 69 Months
Safety Related Events in Part 1B and Part 2
Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests
Number of participants with clinical laboratory abnormalities in specific thyroid tests
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests
Number of participants with clinical laboratory abnormalities in specific liver tests.
Measured: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start31 Jan 2018
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377361
- Sponsor's protocol ID
- CA209-9N9
- Other IDs
- 2017-001830-24, 2017
- Acronym
- CheckMate 9N9
- Status last verified
- Nov 2025
- First submitted
- 14 Dec 2017
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
- ClinicalTrials.gov ID
- NCT03377361
- Acronym / sponsor ID
- CheckMate 9N9 / CA209-9N9
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib | Experimental | Biological: Nivolumab, Drug: Trametinib |
| Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib | Experimental | Biological: Nivolumab, Drug: Trametinib, Biological: Ipilimumab |
| Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib | Experimental | Biological: Nivolumab, Drug: Trametinib, Biological: Ipilimumab |
| Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib | Experimental | Biological: Nivolumab, Drug: Trametinib, Biological: Ipilimumab |
| Part 2 Cohort 5 (3L): Regorafenib | Experimental | Drug: Regorafenib |
| Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib | Experimental | Biological: Nivolumab, Drug: Trametinib, Biological: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
- Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
- Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Key exclusion criteria (8 listed)
- BRAF V600 mutant colorectal cancer
- Active brain metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- History of interstitial lung disease or pneumonitis
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 |
|---|---|---|
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib, Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib, Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib, Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib, Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib |
| TrametinibAlso: MekinistSpecified dose on specified days | Drug | Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib, Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib, Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib, Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib, Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days | Biological | Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib, Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib, Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib, Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib |
| RegorafenibSpecified dose on specified days | Drug | Part 2 Cohort 5 (3L): Regorafenib |
Primary outcome
Dose Limiting Toxicities in Part 1 and Part 1A
Time frame: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen
Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.
Safety Related Events in Part 1 and Part 1 A
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Number of participants with clinical laboratory abnormalities in specific thyroid tests
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)
Number of participants with clinical laboratory abnormalities in specific liver tests.
Overal Response Rate in Part 1B and Part 2
Time frame: Approximately up to 30 Months
ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).
9 secondary outcomes
Objective Response Rate in Part 1 and Part 1A
Time frame: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Disease Control Rate in Part 1 and Part 1A
Time frame: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)
Duration of Response in Part 1 and Part 1A
Time frame: Approximately up to 20 Months
Time to Response in Part 1 and Part 1A
Time frame: From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)
Progression Free Survival in Part 1 and Part 1A
Time frame: from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)
Overall Survival in Part 1 and Part 1A
Time frame: Approximately up to 69 Months
Safety Related Events in Part 1B and Part 2
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests
Time frame: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
47 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab, Trametinib and Ipilimumab in people with Colorectal Cancer and Colorectal Tumors, run by Bristol-Myers Squibb at 47 sites in 10 countries.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Spain, Australia, Argentina, Canada and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities in Part 1 and Part 1A (time frame: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.