Colorectal NeoplasmsPhase 2NEST-1NCT05571293

Combination Immunotherapy in Colorectal Cancer

A Phase 2 study testing Botensilimab and Balstilimab in people with Colorectal Neoplasms, run by Weill Medical College of Cornell University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Neoplasms
What is being tested?: Botensilimab and Balstilimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 3 sitesUnited States
Study dates: 17 Mar 2023to 14 Nov 2024
Phase: Phase 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

18 years of age or older
Histologically, cytologically, or clinically confirmed adenocarcinoma of the colon or rectal cancer as long as there is no plans for neoadjuvant radiation for the patients with rectal cancer. Note: patients can enroll in cohort B while awaiting mismatch repair testing results. If noted to be dMMR/MSI-High, they would be still considered evaluable and moved to cohort C.
If capable of becoming pregnant, or getting someone else pregnant, must be willing to use highly effective contraception from Screening period through 90 days following the last dose of study drug

Who cannot join

Metastatic cancer (cancer that has spread to other parts of the body)
Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1
Currently participating in another study and receiving a study drug
History of severe allergic reactions to immunotherapies
Pregnant or breastfeeding
Active infection requiring treatment

Show all 9Show fewer

On immunosuppressive medications
Active cardiovascular disease, such as stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure, or serious uncontrolled cardiac arrhythmia requiring medication that may prevent surgery
Participants in Cohort C must be dMMR/MSI-High.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Weill Cornell Medicine/NewYork Presbyterian - Queens
Flushing, New York, 11355
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10021

Other trials in United States

About this study

Official title: Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients

This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.

Read the detailed description

This is a pilot study to assess the feasibility, safety, and efficacy of using a combination of a programmed cell death protein 1 (PD-1) inhibitor (balstilimab) and cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor (botensilimab) in the neoadjuvant setting in patients with colorectal cancer, prior to resection. This is a single-center, open-label, pilot study in which patients will receive 2 or 4 doses of intravenous (IV) balstilimab (each dose approximately 2 weeks apart), and a single dose of botensilimab IV, prior to resection in patients with colon cancer. Following surgical resection, participants will return to the clinic for 1-2 post-op follow-up visits.

Conditions: Colorectal Neoplasms
Being tested: Botensilimab, Balstilimab
Keywords: Immunotherapy, Colorectal Cancer, PD-1, CTLA-4
Medical subject headings: Colorectal Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

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

BotensilimabDrug
Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.
BalstilimabDrug
Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description.

Study groups in NCT05571293
Study group	Role	What they receive
Cohort A: Botensilimab and balstilimab (bot/bal)	Experimental	Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab. Receives: Drug: Botensilimab; Drug: Balstilimab
Cohort B:	Experimental	Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Receives: Drug: Botensilimab; Drug: Balstilimab
Cohort C:	Experimental	Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer. Receives: Drug: Botensilimab; Drug: Balstilimab

What is being measured

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

Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort
Resected tumors will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H\&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response), corresponding to Mandard tumor regression grade 1 (CR) or 2 (near-CR). PR will be defined as at least 50% tumor regression. However, considering the lack of consensus on the definition of PR after immunotherapy, tumors with >50% and <90% residual viable tumor will be labeled accordingly as '10-50% tumor regression', as per the NICHE study (Chalabi et. al., 2020). When analyzing pMMR responders versus pMMR nonresponders, this subgroup will be included in the group of nonresponders.
Measured: Immediately following surgical resection of the primary tumor
Cohort A: Number of Participants Who Experience Potentially Treatment-related SAEs According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 Days Following the Last Treatment With Balstilimab or Botensilimab
Safety will be assessed by evaluation of the number of participants experiencing SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days post-the last dose of study drug. Grade 3 or 4 adverse event possibly, probably or definitely attributed to bot/bal. Patients from cohorts B and C were not included in the analysis of this outcome measure per study protocol.
Measured: From date of last dose of study drug up to 90 days after
Cohort A: Number of Participants Who Experience Treatment-related Complications Leading to Delays of 12 Weeks or More in Surgery After Treatment Initiation (Day 0)
Any AEs or SAEs that lead to a delay in surgery greater than 12 weeks from treatment initiation (Day 0) will be recorded. If there are ≥ 2 patients out of the first 6 patients, or ≥ 4 patients out of the full 12 participants (≥33%), with AEs/SAEs that lead to a delay in surgery beyond 12 weeks from treatment initiation, with the exception of COVID-related procedural delays, then this combination of botensilimab and balstilimab, at these dosages will not be considered feasible in this population.
Measured: 12 weeks after treatment initiation date (Day 0)
Cohort C: Composite Rate of Clinical Complete Response or Major Pathological Response at 6 Months
The joint patient-surgeon decision to defer surgery for a watch and wait (Watch-\&-Wait W\&W) approach is allowed as long as the patient is demonstrating sustained response as determined by clinical, radiographic, endoscopic, and/or blood-based biomarkers. For participants who elect to undergo surgery, pathological response will be determined as described above. The key endpoint here will be "Major pathological response (MPR; CR + near-CR). Patients who opt for non-operative management based on clinical response will be considered to have CR. Complete response will be determined by the treating physician and surgeon based on composite subjective and objective assessments of clinical, radiographic, endoscopic, blood-based biomarker assessments, and/or the absence of clinical and radiographic progression.
Measured: 6 months

Secondary outcomes (2)

All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection
Summary statistics including mean, standard deviation will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest.
Measured: Immediately prior to initiation of therapy and 30 days following surgical resection
All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection
Median and range will be provided for ctDNA levels obtained at various time points. Linear mixed-effects models will be used to model longitudinal biomarker values. Simultaneous testing of general linear hypotheses will be used to evaluate contrasts of interest.
Measured: Immediately prior to initiation of therapy and 30 days following surgical resection

Timeline

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

17 Mar 202314 Nov 2024

First posted7 Oct 2022
Study start17 Mar 2023
Primary completion14 Nov 2024
Study completion14 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 NeoplasmsStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05571293
Sponsor's protocol ID: 22-09025238
Acronym: NEST-1
Status last verified: Oct 2026
First submitted: 4 Oct 2022
Last updated: 9 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients
ClinicalTrials.gov ID: NCT05571293
Acronym / sponsor ID: NEST-1 / 22-09025238
Conditions: Colorectal Neoplasms
Keywords: Immunotherapy, Colorectal Cancer, PD-1, CTLA-4
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Agenus Inc.
Study start: 17 Mar 2023 (actual)
Primary completion: 14 Nov 2024 (actual)
Study completion: 14 Nov 2024 (actual)
First posted: 7 Oct 2022 (actual)
Results: Posted 22 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort A: Botensilimab and balstilimab (bot/bal)	Experimental	Drug: Botensilimab, Drug: BalstilimabBotensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab.
Cohort B:	Experimental	Drug: Botensilimab, Drug: BalstilimabBotensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab.
Cohort C:	Experimental	Drug: Botensilimab, Drug: BalstilimabBotensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years of age or older
Histologically, cytologically, or clinically confirmed adenocarcinoma of the colon or rectal cancer as long as there is no plans for neoadjuvant radiation for the patients with rectal cancer. Note: patients can enroll in cohort B while awaiting mismatch repair testing results. If noted to be dMMR/MSI-High, they would be still considered evaluable and moved to cohort C.
If capable of becoming pregnant, or getting someone else pregnant, must be willing to use highly effective contraception from Screening period through 90 days following the last dose of study drug

Key exclusion criteria (9 listed)

Metastatic cancer (cancer that has spread to other parts of the body)
Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1
Currently participating in another study and receiving a study drug
History of severe allergic reactions to immunotherapies
Pregnant or breastfeeding

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
BotensilimabBotensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.	Drug	Cohort A: Botensilimab and balstilimab (bot/bal), Cohort B:, Cohort C:
BalstilimabBalstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description.	Drug	Cohort A: Botensilimab and balstilimab (bot/bal), Cohort B:, Cohort C:

Primary outcome

Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort
Time frame: Immediately following surgical resection of the primary tumor
Resected tumors will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H\&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response), corresponding to Mandard tumor regression grade 1 (CR) or 2 (near-CR). PR will be defined as at least 50% tumor regression. However, considering the lack of consensus on the definition of PR after immunotherapy, tumors with >50% and <90% residual viable tumor will be labeled accordingly as '10-50% tumor regression', as per the NICHE study (Chalabi et. al., 2020). When analyzing pMMR responders versus pMMR nonresponders, this subgroup will be included in the group of nonresponders.
Cohort A: Number of Participants Who Experience Potentially Treatment-related SAEs According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 Days Following the Last Treatment With Balstilimab or Botensilimab
Time frame: From date of last dose of study drug up to 90 days after
Safety will be assessed by evaluation of the number of participants experiencing SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days post-the last dose of study drug. Grade 3 or 4 adverse event possibly, probably or definitely attributed to bot/bal. Patients from cohorts B and C were not included in the analysis of this outcome measure per study protocol.
Cohort A: Number of Participants Who Experience Treatment-related Complications Leading to Delays of 12 Weeks or More in Surgery After Treatment Initiation (Day 0)
Time frame: 12 weeks after treatment initiation date (Day 0)
Any AEs or SAEs that lead to a delay in surgery greater than 12 weeks from treatment initiation (Day 0) will be recorded. If there are ≥ 2 patients out of the first 6 patients, or ≥ 4 patients out of the full 12 participants (≥33%), with AEs/SAEs that lead to a delay in surgery beyond 12 weeks from treatment initiation, with the exception of COVID-related procedural delays, then this combination of botensilimab and balstilimab, at these dosages will not be considered feasible in this population.
Cohort C: Composite Rate of Clinical Complete Response or Major Pathological Response at 6 Months
Time frame: 6 months
The joint patient-surgeon decision to defer surgery for a watch and wait (Watch-\&-Wait W\&W) approach is allowed as long as the patient is demonstrating sustained response as determined by clinical, radiographic, endoscopic, and/or blood-based biomarkers. For participants who elect to undergo surgery, pathological response will be determined as described above. The key endpoint here will be "Major pathological response (MPR; CR + near-CR). Patients who opt for non-operative management based on clinical response will be considered to have CR. Complete response will be determined by the treating physician and surgeon based on composite subjective and objective assessments of clinical, radiographic, endoscopic, blood-based biomarker assessments, and/or the absence of clinical and radiographic progression.

2 secondary outcomes

All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection
Time frame: Immediately prior to initiation of therapy and 30 days following surgical resection
All Cohorts: Changes in Minimal Residual Disease Assessed Using ctDNA Pre- and 30 Days Post-surgical Resection
Time frame: Immediately prior to initiation of therapy and 30 days following surgical resection

Results and safety

Results posted to the registry on 22 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Botensilimab and Balstilimab (Bot/Bal)	12	10
Cohort B:	13	13
Cohort C:	1	1

Primary outcome: Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort

Time frame: Immediately following surgical resection of the primary tumor. Count of participants. Unit: Participants

Measure	Cohort A: Botensilimab and Balstilimab (Bot/Bal) n = 10	Cohort B: n = 13
Value	7	8

Population analysed: The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease. Patients from cohort C were not included in the analysis of this outcome measure per study protocol.

Primary outcome: Cohort A: Number of Participants Who Experience Potentially Treatment-related SAEs According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 Days Following the Last Treatment With Balstilimab or Botensilimab

Time frame: From date of last dose of study drug up to 90 days after. Count of participants. Unit: Participants

Measure	Cohort A: Botensilimab and Balstilimab (Bot/Bal) n = 10
Value	2

Population analysed: The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease. Cohorts B and C were not included in the data analysis for this primary outcome per protocol.

Primary outcome: Cohort A: Number of Participants Who Experience Treatment-related Complications Leading to Delays of 12 Weeks or More in Surgery After Treatment Initiation (Day 0)

Time frame: 12 weeks after treatment initiation date (Day 0). Count of participants. Unit: Participants

Measure	Cohort A: Botensilimab and Balstilimab (Bot/Bal) n = 10
Value	0

Population analysed: This is not appliable for cohorts B and C per the specified study reporting. The analysis population includes all eligible enrolled patients who met protocol-defined criteria and were evaluable for the primary outcome. Two enrolled subjects were excluded from the primary analysis: one subject was determined to be ineligible due to incomplete tumor resection, and one subject was determined to be ineligible after enrollment following identification of metastatic disease.

Primary outcome: Cohort C: Composite Rate of Clinical Complete Response or Major Pathological Response at 6 Months

Time frame: 6 months. Number. Unit: percentage of patients

Measure	Cohort C: n = 1
Value	100

Population analysed: This outcome measure is not applicable to cohorts A and B per the study protocol.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events following initiation of therapy up to 90 days from last treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Botensilimab and Balstilimab (Bot/Bal)	3 of 12 (25%)	4 of 12 (33.3%)	0 of 12
Cohort B:	5 of 13 (38.5%)	10 of 13 (76.9%)	0 of 13
Cohort C:	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Manish Shah, M.D. principal investigator

Weill Medical College of Cornell University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botensilimab and Balstilimab in people with Colorectal Neoplasms, run by Weill Medical College of Cornell University at 3 sites in United States.

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 3 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 22 May 2026). 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?

Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort (time frame: Immediately following surgical resection of the primary tumor). The study lists 4 primary outcomes in all. 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 NCT05571293.

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 9 Oct 2026.