Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Infections

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Stomach Neoplasms

Carcinoma, Hepatocellular

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Microsatellite Instability

Carcinoma, Transitional Cell

Carcinoma, Merkel Cell

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Stomach Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Head and Neck Neoplasms

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Genomic Instability

Stomach Cancer

Renal Cell Carcinoma

Small Cell Lung Cancer

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Turcot Syndrome

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Pembrolizumab

Avelumab

Immunomodulating Agents

Nivolumab

Durvalumab

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor.

1a - Non-small cell lung cancer

1b - Small cell lung cancer

1c - Urothelial carcinoma

1d - Head and neck squamous cell carcinoma

1e - Merkel cell carcinoma

1f - Melanoma

1g - Renal cell carcinoma

1h - Gastric cancer

1i - Cervical cancer

1j - Hepatocellular carcinoma

1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer

Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment.

Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment.

Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.

Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.

Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

N-803 + Pembrolizumab

Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

N-803 + Nivolumab

Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

N-803 + Atezolizumab

Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

N-803 + Avelumab

Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.

N-803 + Durvalumab

Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly

N-803 + Pembrolizumab + PD-L1 t-haNK

Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly

N-803 + Nivolumab + PD-L1 t-haNK

Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly

N-803 + Atezolizumab + PD-L1 t-haNK

Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly

N-803 + Avelumab + PD-L1 t-haNK

Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly

N-803 + Durvalumab + PD-L1 t-haNK

This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N-803, and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.

Assess time from first treatment to death resulting from cancer.

Assess time from first treatment to death resulting from any cause.

Compare changes in QOL scores from baseline.

Assess time from first treatment to disease progression or death from any cause, whichever occurs first.

ImmunityBio, Inc.

Neoplasm Metastasis

Ipilimumab

Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.

Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.

Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.

Stereotactic Body Radiation Therapy 24Gy in 3 fractions.

Stereotactic Body Radiation Therapy (SBRT)

Evan Wuthrick, M.D

The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. This study will test an investigational use of nivolumab.

Participants are randomly assigned in a 1:1 ratio to Arm A (nivolumab + ipilimumab), or Arm B (nivolumab + ipilimumab + SBRT).

Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma

A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma

Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).

Median Progression Free Survival with 95% Confidence Interval. Progression is defined as progressive tumor lesions per immune-related Response Evaluation in Solid Tumors (irRECIST) definition, or appearance of one or more new Merkel cell carcinoma lesions, which can be local or distant in location from the irradiated lesions.

Median Overall Survival with 95% Confidence Interval. The length of time from the start of treatment until death from any cause.

Bristol-Myers Squibb

H. Lee Moffitt Cancer Center and Research Institute

Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.

Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.

Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.

Arm A: Nivolumab + Ipilimumab

Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.

Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.

Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.

Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors	NCT03228667	Non-Small Cell ... Small Cell Lung... Urothelial Carc... Head and Neck S... Merkel Cell Car... Melanoma Renal Cell Carc... Gastric Cancer Cervical Cancer Hepatocellular ... Microsatellite ... Mismatch Repair... Colorectal Canc...	N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu... N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu...	18 Years -	ImmunityBio, Inc.
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors	NCT03228667	Non-Small Cell ... Small Cell Lung... Urothelial Carc... Head and Neck S... Merkel Cell Car... Melanoma Renal Cell Carc... Gastric Cancer Cervical Cancer Hepatocellular ... Microsatellite ... Mismatch Repair... Colorectal Canc...	N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu... N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu...	18 Years -	ImmunityBio, Inc.
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma	NCT03071406	Merkel Cell Car... Skin Cancer	Nivolumab Ipilimumab Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma	NCT03071406	Merkel Cell Car... Skin Cancer	Nivolumab Ipilimumab Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors	NCT03228667	Non-Small Cell ... Small Cell Lung... Urothelial Carc... Head and Neck S... Merkel Cell Car... Melanoma Renal Cell Carc... Gastric Cancer Cervical Cancer Hepatocellular ... Microsatellite ... Mismatch Repair... Colorectal Canc...	N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu... N-803 + Pembrol... N-803 + Nivolum... N-803 + Atezoli... N-803 + Aveluma... N-803 + Durvalu...	18 Years -	ImmunityBio, Inc.

Spots Global Cancer Trial Database for merkel cell carcinoma (mcc)