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Combination Immunotherapies in Patients Who Previously Received Immune Checkpoint Inhibitors (QUILT-3.055)

Combination Immunotherapies in Patients Who Previously Received Immune Checkpoint Inhibitors (QUILT-3.055)

Clinicaltrials.gov identifier:
NCT03228667

Treatment:
Colorectal, Melanoma

Study Contact Information:

For additional information, please contact:

Jayson Garmizo by phone: 310-912-2230 or by email or

Brooke Greenley by phone: 919-810-0367 or by email.


A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors (QUILT-3.055)

About the Study

Immune checkpoint inhibitors are immunotherapy drugs that allow the immune system to find and destroy cancer cells.

This study will use a combination of immunotherapies in people who's cancer got worse after treatment with a PD-1 or PD-L1 immune checkpoint inhibitor.


Type of Study

This is an open-label study. All participants will receive study drugs and all will know which medications they are receiving. Participants will be assigned to one of five groups based on cancer type and response to prior treatment. 


What the Study Entails

All patients in Groups 1-4 will receive treatment with an immune checkpoint inhibitor plus the novel immunotherapy agent N-803 for up to 17 cycles, where each cycle is six weeks in duration.

Some patients in Groups 1-4 whose cancer grows while on study may roll over into Group 5. Group 5 participants will receive treatment with an immune checkpoint inhibitor, the new immunotherapy agents N-803 and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles, where each cycle is six weeks in duration.

Radiologic evaluation will occur at the end of each treatment cycle.

Treatment will continue for up to 2 years, or until the patient experiences progressive disease or an adverse event keeps the participant from continuing in the study.


Study Sites

State City Facility Contact Info
Arkansas Hot Springs Genesis Cancer Center Laura Sellers, RN by phone: 501-624-7700 or email 
Sheila Slone, RN by phone:  501-624-7700 or email
California Fountain Valley MemorialCare Health System Javier Zuniga by phone: 714-378-7496 or email
Marylee Melendrez, CCRP by phone: 562-505-7032 or email  
Glendale Glendale Adventist Medical Center Javier Valeriano by phone: 818-409-8009 or email
Kristin Melendrez by phone: 818-409-8009 or email
Los Angeles University of Southern California,
Norris Comprehensive Cancer Center
Xiomara Menendez, BSN, RN by phone: 323-865-0212 or email
Daisy Sosa by phone: 323-865-0575 or by email    
Rancho Mirage Desert Hematology Oncology Medical Group Carolyn Arrieta by email   
Florida Hollywood Memorial Healcare System Jayme Ion by phone: 954-265-1847 or email 
Angela Aguiar by phone: 954-265-6549 or email
Miami Miami Cancer Institute (Baptist Health South Florida) Winston Dukes, BS by phone: 786-527-8864 or email
Denice Pozo, MBA by phone: 786-527-8564 or email      
Miami University of Miami Maria Pardo by email
Carla Munevar by email  
Indiana Lafayette Horizon Oncology Associates Mariela Torreblanca, CCRC by phone: 765-446-5111 or email
Iowa Iowa City University of Iowa Holden Comprehensive Cancer Center  

Heidi Haughland, RN, BSN, OCN by phone: 319-384-5285 or email

Kentucky Lexington Baptist Health Karli Heasley by email
Cortney Grimes by phone: 589-260-3196 or email
Louisville Baptist Health Renee Dickerson by phone: 502-897-1166 ext 1403 or email
Massachusetts Boston Dana-Farber Cancer Institute Molly Sullivan, BSN by email
Michigan Detroit Henry Ford Hospital Trevor I Seixas by phone: 313-916-0482 or email
Minnesota Minneapolis Masonic Cancer Center Nicole Sando by phone: 612-624-5949 or email
Ali Kahlert by phone: 612-301-1761 or email
Missouri Joplin Mercy Research Joplin Esmeralda Carrillo by email
St. Louis Washington University School of Medicine Joe Murphy by phone: 314-273-2686 or email
Katlyn Kraft by phone: 314-747-5440 or email 
Montana Billings St. Vincent Frontier Cancer Center Sabrina Leonhardt by phone: 406-238-6290 or email
Tina Erhardt by phone: 406-238-6962 or email
New Hampshire Lebanon Dartmouth-Hitchcock Medical Center Kristina Willey by phone: 603-650-7705 ext 57705 or email
Marylynne Strachan by phone: 603-650-2995 or email
New York Buffalo Roswell Park Cancer Institute Daisy Rochez by phone: 716-845-1657 or email
Ohio Cleveland Cleveland Clinic Makenzie Guy by phone: 216-445-8492 or email
Oregon Portland Providence Portland Medical Center Kim Sutcliffe, RN by phone: 503-215-5696 or email
Mitch Clemens, CCRP by phone: 503-215-7491 or email
South Carolina Charleston Medical University of South Carolina Alexandra Leitner by phone: 843-792-1507 or email
Greenville St. Francis Cancer Center Gina Smith by email
South Dakota Souix Falls Sanford Clinical Research Jane Veerman by phone: 605-328-1373 or email
Staci Vogel, RN by phone: 605-312-3336 or email
Tennessee Knoxville University of Tennesse Medical Center Brenna Adelman by phone: 865-305-5131 or email
Emily Byers by email
Texas Houston Oncology Consultants of Houston Rozeen Badeel by phone: 713-275-3207 or email
Laura Guerra by phone: 713-600-0913 or.email
Virginia Richmond Bon Secours Richmond Melissa Godsey by phone: 804-893-8611 or email 
Mary Williams by email 
This Study is Open To:

Men or women age 18 years or older are eligible to participate if they meet criteria as defined in any one of the following groups:

  • unresectable or metastatic MSI-H or dMMR solid tumors (MMR is caused by mutations in genes that fix DNA damage in cells and common in people with Lynch syndrome) disease progression on or after taking nivolumab as a single agent or in combo with ipilimumab, or disease progression on or after taking pembrolizumab
  • metastatic melanoma disease progression on or after taking pembrolizumab, or taking nivolumab (single-agent), in combo with ipilimumab, or as a subsequent therapy
  • people with the following cancers who had progression or recurrence after treatment with an immune checkpoint inhibitor may also qualify:
    • lung cancer: metastatic squamous or nonsquamous non-small-cell lung carcinoma (NSCLC), metastatic small-cell lung carcinoma (SCLC)
    • locally advanced or metastatic urothelial (urinary) cancer
    • recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) disease
    • metastatic Merkel cell carcinoma (MCC, a type of skin cancer)
    • advanced renal (kidney) cell carcinoma
    • recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma disease
    • progression, recurrent or metastatic cervical cancer, hepatocellular (liver-related) cancer 
This Study is Not Open To:

Patients may not participate if they have:  

  • Central nervous system (CNS) metastases (contact the study team or visit clinicaltrials.gov to review exceptions)
  • Severe cardiac dysfunction
  • Autoimmune disease requiring active treatment
  • Inflammation of the tissue that surrounds the lung's air sacs, blood vessels and airways, and/or immune mediated pneumonitis (inflammation of lung tissue).
  • HIV-positive
  • Active systemic infection requiring non-oral antibiotic therapy
  • Hepatitis C or Hepatitis B
  • Have had previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, in situ gastric or in situ colon cancers, in situ cervical cancers/dysplasia or breast carcinoma in situ) unless a complete remission was achieved at least 1 year prior to study entry. This exclusion does not apply to patients enrolling in cohort 5.
  • Patients in which treatment with an immune checkpoint inhibitor is not advised
  • Women who are pregnant or nursing