Head and Neck CancerPhase 1NCT04722523
A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
A Phase 1 study testing Cisplatin, Carboplatin and Docetaxel in people with Head and Neck Cancer and Head Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head Cancer, Head Cancer Neck
- What is being tested?
- Cisplatin, Carboplatin and Docetaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jan 2021to 20 Jun 2027
- Phase
- 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
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx
- Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy.
- ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.
- Disease must be amenable to surgical resection.
- The patient must be a surgical candidate.
- Hemoglobin > 9.0 g/dL
Show all 15Show fewer
- Absolute neutrophil count (ANC) >1.5 x 10^9/L
- Platelet count >100 x 10^9/L
- Serum creatinine <1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) >30 mL/min
- Adequate hepatic function:
- Total bilirubin <1.5 x upper limit of normal ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both < 3 x ULN
- Alkaline phosphatase (ALP) <2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin <3x ULN. Upper central must be documented appropriately as past medical history.
- Men and woman >18 years old
- Eastern cooperative oncology group performance status < 1
Who cannot join
- Prior radiation and systemic therapy for a head and neck cancer.
- Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.
- Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years.
- Exceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.
- Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.
- Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.
Show all 25Show fewer
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
- Any infection requiring hospitalization and/or intravenous antibiotic therapy within 2 weeks of the start of treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.
- Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards
- Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab.
- Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.
- History of immune-related pneumonitis with the last 5 years.
- History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management.
- Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
- Patients with a history of solid organ transplant (exception: corneal transplant)
- Any medical comorbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that in the opinion of the investigator renders the patient unsuitable for participation in a clinical trial due to high safety risks.
- Women with a positive serum or urine beta-hCG pregnancy test at screening/baseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.
- Breast-feeding women
- Women of childbearing potential who are sexually active and aren't willing to practice highly effective contraception prior to the first dose of Cemiplimab, during the study, and for at least 180 days after the last dose. Highly effective contraceptive measures include:
- Stable use of combined estrogen and progesterone containing hormonal contraception or progesterone and-only hormonal contraception associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
- Intrauterine device; intrauterine hormone-releasing system
- Bilateral tubal ligation
- Vasectomized partner and/or
- Sexual abstinence
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Lara Dunn, MD, 646-608-3787, dunnl1@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725
Laura Dunn, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Lara Dunn, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Lara Dunn, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Lara Dunn, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lara Dunn, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Laura Dunn, MD, 646-608-3787
About this study
Official title: A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.
- Conditions
- Head and Neck Cancer, Head Cancer, Head Cancer Neck, Neck Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC
- Being tested
- Cisplatin, Carboplatin, Docetaxel, Cetuximab, Cemiplimab
- Keywords
- Cemiplimab, Platinum-Doublet Chemotherapy, Cetuximab, Head and Neck Cancer, Head Cancer, Neck Cancer, Head and Neck Squamous Cell Carcinoma, Memorial Sloan Kettering Cancer Center, 20-445, HNSCC)
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 75mg/m2 AUC 5 on weeks 2, 5, and 8
CarboplatinDrug
Carboplatin AUC 5 on weeks 2, 5, and 8
DocetaxelDrug
Docetaxel 75mg/m2 on weeks 2, 5, and 8
CetuximabDrug
Cetuximab 400mg/m2 on week 1, 250mg/m2 on weeks 2, 3, 4, 5, 6, 7, 8, 9, 10
CemiplimabDrug
Cemiplimab 350mg on weeks 2, 5, 8, 11; if adjuvant radiation +/- chemotherapy is omitted, Cemiplimab will be administered on weeks 16, 19, 22, 25, 28, 31, 34, 37
Surgical Resection of Primary +/- Neck DissectionProcedure or surgery
Twenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).
Post-operative radiation therapyRadiation
Post-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic stage following induction systemic therapy and surgery is ypT1-2N0 without the presence of adverse features that include positive margins or a combination of perineural invasion, vascular invasion, and a depth of invasion of >0.5mm, adjuvant radiation will not be administered, consistent with the NCCN guidelines [2]. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.
PaclitaxelDrug
Also called Taxol
If participants are unable to receive Docetaxel due to lack of insurance approval or due to an allergic reaction, Docetaxel can be substituted with Paclitaxel. Paclitaxel would be dosed at 90 mg/m2 on weeks 2, 3, 5, 6, 8 and 9.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Squamous Cell Cancer/HNSCC | Experimental | Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Docetaxel; Drug: Cetuximab; Drug: Cemiplimab; Procedure: Surgical Resection of Primary +/- Neck Dissection; Radiation: Post-operative radiation therapy; Drug: Paclitaxel |
| Secondary Cohort | Experimental | Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. Receives: Drug: Cetuximab; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicities graded according to NCI CTCAE
The primary endpoint is safety and tolerability, which will be evaluated by a description of observed adverse events by grades. All toxicities will be graded according to NCI CTCAE, Version5.0. The regimen will be deemed safe and well tolerated if there are 2 or fewer DLTs out of 10 patients enrolled. A DLT is defined as any non-hematologic grade 3 or greater adverse event as defined by CTCAE v5.0 that is thought to be related to the addition of Cemiplimab to the combination of a platinum-doublet with cetuximab.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start20 Jan 2021
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Six patients can be enrolled once the study has opened to the starting dose level. If 0-1 of the first 6 patients treated on study experience a DLT, then an additional 4 patients will be accrued to the study. If 0-2 of the 10 patients experience a DLT, then the combination will be deemed to be safe. If \>2 of the first 6 patients accrued or \>3 of 10 patients accrued experience a DLT, then patients will be treated at one dose level reduction.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Lara Dunn, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722523
- Sponsor's protocol ID
- 20-445
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04722523
- Acronym / sponsor ID
- 20-445
- Conditions
- Head and Neck Cancer, Head Cancer, Head Cancer Neck, Neck Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC
- Keywords
- Cemiplimab, Platinum-Doublet Chemotherapy, Cetuximab, Head and Neck Cancer, Head Cancer, Neck Cancer, Head and Neck Squamous Cell Carcinoma, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 25 Jan 2021 (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.
The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Six patients can be enrolled once the study has opened to the starting dose level. If 0-1 of the first 6 patients treated on study experience a DLT, then an additional 4 patients will be accrued to the study. If 0-2 of the 10 patients experience a DLT, then the combination will be deemed to be safe. If >2 of the first 6 patients accrued or >3 of 10 patients accrued experience a DLT, then patients will be treated at one dose level reduction.
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Squamous Cell Cancer/HNSCC | Experimental | Drug: Cisplatin, Drug: Carboplatin, Drug: Docetaxel, Drug: Cetuximab, Drug: Cemiplimab, Procedure: Surgical Resection of Primary +/- Neck Dissection, Radiation: Post-operative radiation therapy, Drug: PaclitaxelParticipants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. |
| Secondary Cohort | Experimental | Drug: Cetuximab, Drug: CemiplimabParticipants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx
- Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy.
- ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.
- Disease must be amenable to surgical resection.
- The patient must be a surgical candidate.
Key exclusion criteria (25 listed)
- Prior radiation and systemic therapy for a head and neck cancer.
- Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.
- Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years.
- Exceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.
- Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.
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 |
|---|---|---|
| CisplatinCisplatin 75mg/m2 AUC 5 on weeks 2, 5, and 8 | Drug | Head and Neck Squamous Cell Cancer/HNSCC |
| CarboplatinCarboplatin AUC 5 on weeks 2, 5, and 8 | Drug | Head and Neck Squamous Cell Cancer/HNSCC |
| DocetaxelDocetaxel 75mg/m2 on weeks 2, 5, and 8 | Drug | Head and Neck Squamous Cell Cancer/HNSCC |
| CetuximabCetuximab 400mg/m2 on week 1, 250mg/m2 on weeks 2, 3, 4, 5, 6, 7, 8, 9, 10 | Drug | Head and Neck Squamous Cell Cancer/HNSCC, Secondary Cohort |
| CemiplimabCemiplimab 350mg on weeks 2, 5, 8, 11; if adjuvant radiation +/- chemotherapy is omitted, Cemiplimab will be administered on weeks 16, 19, 22, 25, 28, 31, 34, 37 | Drug | Head and Neck Squamous Cell Cancer/HNSCC, Secondary Cohort |
| Surgical Resection of Primary +/- Neck DissectionTwenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s). | Procedure or surgery | Head and Neck Squamous Cell Cancer/HNSCC |
| Post-operative radiation therapyPost-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic stage following induction systemic therapy and surgery is ypT1-2N0 without the presence of adverse features that include positive margins or a combination of perineural invasion, vascular invasion, and a depth of invasion of >0.5mm, adjuvant radiation will not be administered, consistent with the NCCN guidelines [2]. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques. | Radiation | Head and Neck Squamous Cell Cancer/HNSCC |
| PaclitaxelAlso: TaxolIf participants are unable to receive Docetaxel due to lack of insurance approval or due to an allergic reaction, Docetaxel can be substituted with Paclitaxel. Paclitaxel would be dosed at 90 mg/m2 on weeks 2, 3, 5, 6, 8 and 9. | Drug | Head and Neck Squamous Cell Cancer/HNSCC |
Primary outcome
Incidence of toxicities graded according to NCI CTCAE
Time frame: 1 year
The primary endpoint is safety and tolerability, which will be evaluated by a description of observed adverse events by grades. All toxicities will be graded according to NCI CTCAE, Version5.0. The regimen will be deemed safe and well tolerated if there are 2 or fewer DLTs out of 10 patients enrolled. A DLT is defined as any non-hematologic grade 3 or greater adverse event as defined by CTCAE v5.0 that is thought to be related to the addition of Cemiplimab to the combination of a platinum-doublet with cetuximab.
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 21 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Lara Dunn, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin, Carboplatin and Docetaxel in people with Head and Neck Cancer and Head Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 15 inclusion and 25 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
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 Lara Dunn, MD (646-608-3787, dunnl1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicities graded according to NCI CTCAE (time frame: 1 year). 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 21 Jul 2026.