Non-MSI-H or pMMR Colorectal Cancer With Liver MetastasisEarly Phase 1NCT07128355
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
A Early Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Botensilimab and Balstilimab in people with Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Botensilimab and Balstilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to Sep 2027
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin.
- MSS or pMMR status confirmed by IHC or PCR.
- Must have at least 1 measurable (≥ 1 cm) previously unirradiated hepatic lesion amenable to ablative RT and meeting dose constraints. A maximum of 5 hepatic lesions are allowed provided all are amenable to ablative RT and meet dose constraints. Must have at least 1 other unirradiated measurable (≥ 1cm) extrahepatic lesion, outside of RT field. Patients should ideally have a second unirradiated lesion, outside of RT field, that would be amenable for paired biopsies.
- Must have received or confirmed intolerance to 5-FU, Oxaliplatin, and Irinotecan (in any combination).
- Age ≥18 years
- ECOG performance status ≤ 1
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- Life expectancy of greater than 3 months.
- Participants must meet the following organ and marrow function as defined below:
- Absolute Neutrophil Count (ANC) ≥ 1500 /mcL
- White Blood Cells (WBC) ≥ 2000 /mcL
- Platelets (PLT) ≥ 100,000 /mcL
- Hemoglobin (HGB) ≥ 8 g/dL without transfusion within 2 weeks of measurement
- AST and ALT ≤ 2.5 x ULN
- Total Bilirubin ≤ 1.5 x ULN OR < 3 mg/dL for participants with Gilbert Syndrome
- Creatinine Clearance ≥ 40 mL/min if calculated using Cockcroft-Gault formula
- The effects of radiation on the developing human fetus are known to be teratogenic and the safety of Botensilimab and Balstilimab in pregnant women and their fetuses has not been established.
- --Woman of childbearing potential (WOCBP) and men with WOCBP partners must agree to use highly effective contraceptive measures starting at screening through 5 months (180 days) after the last dose of balstilimab and/or botensilimab.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG).
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days prior to starting protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
- EXCEPTION: Participants with ≤ Grade 2 neuropathy are permitted.
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting protocol treatment.
- Known or suspected, active, autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration.
- --EXCEPTIONS: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if >10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
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- Positive TB (Bacillus Tuberculosis) at screening. NOTE: skin test is not allowed. Interferon-Gamma Release Assay (IGRA)-based tests such as QuantiFERON TB Gold and T-Spot TB tests are acceptable.
- Partial or complete bowel obstruction within the last 3 months, signs/ symptoms of bowel obstruction, or known radiologic evidence of impeding obstruction.
- Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks, or ≥ times within the last 90 days, or ≥ time within the last 2 weeks prior to study entry, or requiring diuretics within 2 weeks of study entry.
- Known history of active or chronic HBV or HCV infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- -- EXCEPTIONS: Patients with CD4 >200 cells/mm3 and/or undetectable viral load are eligible.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Participant is pregnant, breastfeeding, expecting to conceive, or father children within the projected duration of the trial, starting with the consent visit through 120 days for woman and 120 days for men, after the last dose of study treatment.
- There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation, breastfeeding should be discontinued if the mother is treated with radiation.
- Known history of, or any evidence of active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Has received a live vaccine within 30 days of planned start of study therapy. Intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- --EXCEPTION: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any study agents.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Uncontrolled brain metastases. Participants treated with radiation > 4 weeks prior to registration, with follow up imaging showing control are eligible.
- Participants who present with significant active diarrhea.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Aparna R. Parikh, MD, 617-724-4000, aparna.parikh@mgh.harvard.edu
Aparna R. Parikh, MD
About this study
Official title: A Pilot Study of Botensilimab and Balstilimab and SBRT in Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
Read the detailed description
In this open-label study, the investigators propose to use standard of care (SOC) radiation (Stereotactic Body Radiation Therapy (SBRT)) to control the liver lesions in combination with investigational dual checkpoint inhibitors, botensilimab (AGEN1181) and balstilimab (AGEN2034).
Initially, 5 patients will be enrolled in a lead-in cohort and assessed for dose-limiting toxicity (DLT) related to radiation during Cycle 1. If DLT are observed in 2 or more of the first 5 patients, the protocol will be stopped early. If DLT were observed in 0 or 1 of the first 5 patients during the lead-in, enrollment will be expanded to a total of 15 patients. After screening, participants will receive SOC SBRT for 2-3 weeks, and botensilimab + balstilimab for up to 24 weeks followed by balstilimab alone for 14 additional 6-week cycles, for a total treatment time of up to 108 weeks. Participants will be followed for 1 year.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Botensilimab, Balstilimab
- Keywords
- colorectal cancer, colorectal cancer with liver metastasis, Non-MSI-H or pMMR Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called SBRT
Starting on Day 1 participants will have 2-4 treatments per week for about 2 weeks, with no more than 2 days in a row. This is expected to last about 2 weeks but could last up to 3 weeks.
BotensilimabDrug
Also called AGEN1181
Administered once every 6 weeks by intravenous infusion over about 30 minutes, on Day 1 of Cycles 1-4 (six-week cycles). Administered 30 minutes after balstilimab.
BalstilimabDrug
Also called AGEN2034
Administered once every 2 weeks by intravenous infusion over about 30 minutes, starting on Day 1 of Cycle 1 and continuing for 4 six-week cycles (with botensilimab) followed by up to 14 six-week cycles of balstilimab alone. Participants will receive balstilimab for a total of 18 six-week cycles.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab | Experimental | Participants will receive:
* standard of care (SOC) SBRT for 2-3 weeks (Cycle 1);
* botensilimab, on Day 1 of 6-week cycles (Cycles 1-4);
* balstilimab, once every 2 weeks (Cycles 1-18, 6-week cycles). Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Botensilimab; Drug: Balstilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting radiation-related toxicities
Dose limiting radiation-related toxicities will be assessed by CTCAE v6.0. A dose limiting toxicity (DLT) will be defined as any patient who can't complete all radiation therapy (RT) fractions within 2-3 weeks for pre-specified toxicity or lab values attributable to radiation therapy, or development of RT-related toxicities within 30 days of completion of RT. Participants will be evaluable for DLT once they start protocol therapy.
Measured: Day 1 of treatment through 30 days after completion of radiation therapy (radiation therapy is 2-3 weeks), up to 60 days.
Secondary outcomes (5)
Response rate of in-field radiated hepatic lesion(s)
The response rate (Complete Response (CR), Partial Response (PR)) of irradiated hepatic lesions by RECIST 1.1 will be estimated as a proportion with 95% confidence intervals based on the exact binomial distribution by RECIST.
Measured: Screening through end of Cycle 18 (each cycle is 6 weeks), up to 108 weeks.
Response rate of extrahepatic lesion(s)
The response rate (Complete Response (CR), Partial Response (PR)) of unirradiated extrahepatic lesions by RECIST 1.1 will be estimated with 95% confidence intervals based on the exact binomial distribution.
Measured: Screening through end of Cycle 18 (each cycle is 6 weeks), up to 108 weeks.
Overall Survival (OS)
OS is defined as time from registration to death due to any cause or censored at date last known alive. OS rates will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: Registration through 160 weeks (108 weeks of treatment + 1 year follow-up)
Progression-Free Survival (PFS)
PFS is defined as time from registration to the earlier of progression (per RECIST 1.1) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. PFS rates will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Measured: Registration through up to 108 weeks of treatment
Disease Control Rate (DCR)
Disease control is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Response is measured by RECIST 1.1. The cumulative incidence will be estimated with patients still alive with disease control censored at the date of last disease assessment and death without disease analyzed as a competing risk.
Measured: Day 1 through up to 108 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2025
- Study start12 May 2026
- Primary completion1 Jan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-MSI-H or pMMR Colorectal Cancer With Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agenus Inc.
- Responsible party
- Principal investigator, Aparna Parikh, Massachusetts General Hospital
- Investigators
- Aparna R. Parikh, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128355
- Sponsor's protocol ID
- 25-495
- Status last verified
- May 2026
- First submitted
- 13 Aug 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the PI, Aparna Raj Parikh, MD, MS (aparna.parikh@mgh.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Botensilimab and Balstilimab and SBRT in Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT07128355
- Acronym / sponsor ID
- 25-495
- Keywords
- colorectal cancer, colorectal cancer with liver metastasis, Non-MSI-H or pMMR Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Agenus Inc.
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Aug 2025 (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.
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
Detailed description
In this open-label study, the investigators propose to use standard of care (SOC) radiation (Stereotactic Body Radiation Therapy (SBRT)) to control the liver lesions in combination with investigational dual checkpoint inhibitors, botensilimab (AGEN1181) and balstilimab (AGEN2034).
Initially, 5 patients will be enrolled in a lead-in cohort and assessed for dose-limiting toxicity (DLT) related to radiation during Cycle 1. If DLT are observed in 2 or more of the first 5 patients, the protocol will be stopped early. If DLT were observed in 0 or 1 of the first 5 patients during the lead-in, enrollment will be expanded to a total of 15 patients. After screening, participants will receive SOC SBRT for 2-3 weeks, and botensilimab + balstilimab for up to 24 weeks followed by balstilimab alone for 14 additional 6-week cycles, for a total treatment time of up to 108 weeks. Participants will be followed for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: Botensilimab, Drug: BalstilimabParticipants will receive: * standard of care (SOC) SBRT for 2-3 weeks (Cycle 1); * botensilimab, on Day 1 of 6-week cycles (Cycles 1-4); * balstilimab, once every 2 weeks (Cycles 1-18, 6-week cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin.
- MSS or pMMR status confirmed by IHC or PCR.
- Must have at least 1 measurable (≥ 1 cm) previously unirradiated hepatic lesion amenable to ablative RT and meeting dose constraints. A maximum of 5 hepatic lesions are allowed provided all are amenable to ablative RT and meet dose constraints. Must have at least 1 other unirradiated measurable (≥ 1cm) extrahepatic lesion, outside of RT field. Patients should ideally have a second unirradiated lesion, outside of RT field, that would be amenable for paired biopsies.
- Must have received or confirmed intolerance to 5-FU, Oxaliplatin, and Irinotecan (in any combination).
- Age ≥18 years
Key exclusion criteria (24 listed)
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days prior to starting protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
- Known or suspected, active, autoimmune disease
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration.
- --EXCEPTIONS: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if >10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
- Positive TB (Bacillus Tuberculosis) at screening. NOTE: skin test is not allowed. Interferon-Gamma Release Assay (IGRA)-based tests such as QuantiFERON TB Gold and T-Spot TB tests are acceptable.
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: SBRTStarting on Day 1 participants will have 2-4 treatments per week for about 2 weeks, with no more than 2 days in a row. This is expected to last about 2 weeks but could last up to 3 weeks. | Radiation | Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab |
| BotensilimabAlso: AGEN1181Administered once every 6 weeks by intravenous infusion over about 30 minutes, on Day 1 of Cycles 1-4 (six-week cycles). Administered 30 minutes after balstilimab. | Drug | Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab |
| BalstilimabAlso: AGEN2034Administered once every 2 weeks by intravenous infusion over about 30 minutes, starting on Day 1 of Cycle 1 and continuing for 4 six-week cycles (with botensilimab) followed by up to 14 six-week cycles of balstilimab alone. Participants will receive balstilimab for a total of 18 six-week cycles. | Drug | Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab |
Primary outcome
Incidence of dose limiting radiation-related toxicities
Time frame: Day 1 of treatment through 30 days after completion of radiation therapy (radiation therapy is 2-3 weeks), up to 60 days.
Dose limiting radiation-related toxicities will be assessed by CTCAE v6.0. A dose limiting toxicity (DLT) will be defined as any patient who can't complete all radiation therapy (RT) fractions within 2-3 weeks for pre-specified toxicity or lab values attributable to radiation therapy, or development of RT-related toxicities within 30 days of completion of RT. Participants will be evaluable for DLT once they start protocol therapy.
5 secondary outcomes
Response rate of in-field radiated hepatic lesion(s)
Time frame: Screening through end of Cycle 18 (each cycle is 6 weeks), up to 108 weeks.
Response rate of extrahepatic lesion(s)
Time frame: Screening through end of Cycle 18 (each cycle is 6 weeks), up to 108 weeks.
Overall Survival (OS)
Time frame: Registration through 160 weeks (108 weeks of treatment + 1 year follow-up)
Progression-Free Survival (PFS)
Time frame: Registration through up to 108 weeks of treatment
Disease Control Rate (DCR)
Time frame: Day 1 through up to 108 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the PI, Aparna Raj Parikh, MD, MS (aparna.parikh@mgh.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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.
Aparna R. Parikh, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT), Botensilimab and Balstilimab in people with Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis, run by Massachusetts General Hospital at 1 site 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 20 inclusion and 24 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 13 May 2026. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Aparna R. Parikh, MD (617-724-4000, aparna.parikh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting radiation-related toxicities (time frame: Day 1 of treatment through 30 days after completion of radiation therapy (radiation therapy is 2-3 weeks), up to 60 days.). 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 13 May 2026.