Recruiting
Phase 2

BMS-986016

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06029270

Conditions

Metastatic Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma

Stage IV Nasopharyngeal Carcinoma AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Scan

Carboplatin

Cisplatin

Computed Tomography

Study Details

Brief summary:

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

Conditions

Metastatic Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma

Stage IV Nasopharyngeal Carcinoma AJCC v8

Study ID

NCT06029270

Start date

Jul 15, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION:
  • Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and/or is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics:

  • Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or
  • A known history of detectable plasma EBV DNA (via a polymerase chain reaction \[PCR\]-based assay) at any time point since the initial diagnosis of NPC.
  • Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.

  • Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.
  • CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated).
  • Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional.
  • Symptomatic and active brain metastases and/or leptomeningeal metastasis on CT and/or MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord/cauda compression who are clinically stable for >= 2 months prior to registration and have discontinued systemic steroids therapy (> 10 mg/day prednisone or equivalent) > 4 weeks prior to registration are eligible.
  • Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and/or significant vasogenic edema on radiological imaging.
  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.
  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
  • Absolute neutrophil count (ANC) >= 1500 cells/mm\^3.
  • Platelets >= 100,000 cells/mm\^3.
  • Hemoglobin (Hgb) >= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.).
  • Total bilirubin =< 1.5 × institutional upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level =< 3 × ULN may be enrolled.
  • Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =< 3 × ULN (=< 5 × ULN for patients with liver metastases).
  • Serum creatinine =< 1.5 × ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation >= 30 mL/min for patients with serum creatinine levels > 1.5 × ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL/min, for whom carboplatin should be used instead of cisplatin. CrCl must be > 50 mL/min for cisplatin to be used.
  • Albumin-adjusted calcium level based on corrected calcium equation =< 1.5 × ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment).
  • No prior systemic treatment of palliative intent for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence.
  • No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and/or induction, concurrent, or adjuvant chemotherapy and recurrence must be ˃ 6 months.
  • Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed.
  • No prior palliative RT within 30 days prior to registration unless the irradiated site(s) are not the target lesions. The irradiated site(s) also must not be the only sites of measurable recurrent disease.
  • No major surgical procedures within 30 days prior to registration.
  • No history of unstable angina requiring hospitalization within the last 6 months.
  • No history of myocardial infarction within the last 6 months.
  • New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction < 50% must be stably controlled with medication in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
  • No prior history of myocarditis.
  • No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments at the time of study registration.
  • No history of (non-infectious) pneumonitis that required steroids or current pneumonitis requiring steroids and/or immunosuppressive therapy, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), or idiopathic pneumonitis.
  • No history of multi-drug resistant mycobacterium tuberculosis (TB) or active TB, as defined by systemic treatment received =< 2 years prior to registration. Note: Patients who had a history of treated TB ˃ 2 years prior to registration are allowed.
  • No prior solid organ transplant or bone marrow transplant.
  • No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid premedication for the prophylaxis of CT contrast-related allergies is allowed. The use of dexamethasone as an anti-emetic premedication prior to chemotherapy is also allowed.
  • No active autoimmune disease requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These may include (but not limited to) patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, autoimmune hepatitis, glomerulonephritis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome.

  • Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; alopecia; and/or psoriasis not requiring systemic treatment. Conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • No prior live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines that are approved by the local drug regulatory authority of the participating region are allowed.
  • No known history of grade 3-4 allergic reaction or hypersensitivity reaction to cisplatin, carboplatin, or gemcitabine.
  • No known history of grade 4 hypersensitivity (or infusion) reaction to any monoclonal antibody. Patients who had prior grade 3 hypersensitivity (or infusion) reaction but could tolerate resumption of the antibody treatment after appropriate pre-medication are eligible.
  • PRIOR TO STEP 2 REGISTRATION:
  • Collection of plasma EBV DNA at baseline is mandatory for all patients prior to Step 2 registration and induction treatment.

  • Note: Submission of the baseline sample will be batch shipped.
  • PRIOR TO STEP 3 REGISTRATION/RANDOMIZATION: PATIENTS WITHOUT PROGRESSIVE DISEASE (PD) ONLY:
  • All patients must have received minimum of 3 cycles, and up to a maximum of 6 cycles of induction treatment within 20 weeks from cycle 1, day 1 of induction treatment (i.e., patients must have completed all induction treatment within 20 weeks from cycle 1 day 1, including the treatment breaks). Patients must have completed 6 cycles of induction treatment, except in the following circumstances:

  • Significant dose delays as a result of treatment-related toxicities.
  • Intercurrent illness(s), that rendered the patient unable to continue induction treatment.
  • Note: If a patient received < 6 cycles of induction treatment for reasons other than the above circumstances, they will not be eligible for randomization.
  • A CT scan within 30 days prior to Step 3 registration/randomization is required. If the most recent scan performed is not within this time frame, a repeat scan is required to assess response.
  • Did not meet any criteria that result in permanent discontinuation of study treatment during induction treatment phase.
  • Must meet the criteria for starting/resuming a new cycle of maintenance treatment.
  • Did not experience any nivolumab-related autoimmune toxicities that would result in permanent discontinuation of nivolumab during the induction treatment phase.
  • Collection of the plasma EBV DNA post-induction treatment is mandatory.

  • Note: Submission of the post-induction sample will be batch shipped.

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (Nivolumab)

Patients receive nivolumab IV over 30 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo PET/CT or bone scan as clinically indicated.

experimental: Arm II (Nivolumab, relatlimab)

Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30-90 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo PET/CT or bone scan as clinically indicated.

experimental: Induction therapy (Platinum-gemcitabine-nivolumab)

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, cisplatin IV or carboplatin IV over 30-60 minutes on day 1 of each cycle and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and blood sample collection during screening and on study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Bone Scan

Undergo bone scan

Carboplatin

Given IV

Cisplatin

Given IV

Computed Tomography

Undergo CT or PET/CT

Gemcitabine

Given IV

Magnetic Resonance Imaging

Undergo MRI

Nivolumab

Given IV

Positron Emission Tomography

Undergo PET/CT

Relatlimab

Given IV

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: Time from randomization to progressive disease (PD) or death due to any cause, assessed up to 6 years ]

Central Contacts and Locations

Locations

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Keck Medicine of USC Koreatown

Recruiting

Los Angeles, California, United States, 90020

Contacts

Site Public Contact

213-388-0908

Principal Investigator:

Jacob S. Thomas

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Jacob S. Thomas

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Jacob S. Thomas

Kaiser Permanente- Modesto MOB II

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

USC Norris Oncology/Hematology-Newport Beach

Recruiting

Newport Beach, California, United States, 92663

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Jacob S. Thomas

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Alexander D. Colevas

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

Contacts

Site Public Contact

877-642-4691kpoct@kp.org

Principal Investigator:

Jed A. Katzel

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Siao-Yi Wang

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Jed A. Katzel

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Conor E. Steuer

Kaiser Permanente Moanalua Medical Center

Recruiting

Honolulu, Hawaii, United States, 96819

Contacts

Principal Investigator:

Jed A. Katzel

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Jochen H. Lorch

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Ameen Salahudeen

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Jochen H. Lorch

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Jochen H. Lorch

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Jochen H. Lorch

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Jochen H. Lorch

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Jochen H. Lorch

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Jochen H. Lorch

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Jochen H. Lorch

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Saint Anthony Regional Hospital

Recruiting

Carroll, Iowa, United States, 51401

Contacts

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Methodist Jennie Edmundson Hospital

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Principal Investigator:

Yungpo B. Su

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Principal Investigator:

Yungpo B. Su

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Healthcare Mission Cancer and Blood - Fort Dodge

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-354-5144

Principal Investigator:

Yungpo B. Su

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Minh Phan

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Dan S. Zuckerman

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

John M. Kaczmar

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Dan S. Zuckerman

ProHealth D N Greenwald Center

Recruiting

Mukwonago, Wisconsin, United States, 53149

Contacts

Site Public Contact

research.institute@phci.org

Principal Investigator:

Timothy R. Wassenaar

ProHealth Oconomowoc Memorial Hospital

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Site Public Contact

262-928-7878

Principal Investigator:

Timothy R. Wassenaar

ProHealth Waukesha Memorial Hospital

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-7632

Principal Investigator:

Timothy R. Wassenaar

UW Cancer Center at ProHealth Care

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Principal Investigator:

Timothy R. Wassenaar

University Health Network-Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Principal Investigator:

Enrique Sanz Garcia

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.