QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)

NCT02465957 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: QUILT-3.009MCC-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

Phase II study to determine the effects of aNK infusions in combination with ALT-803 in patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).

Conditions

Stage IIIB Merkel Cell Carcinoma; Stage IV Merkel Cell Carcinoma

Keywords

Merkel Cell Carcinoma; Neukoplast; NK-92; Natural Killer Cell; MCC; aNK

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival Rate at 4 Months

  4 months

Study Arms (2)

aNK (NK-92)

EXPERIMENTAL

aNK (activated NK-92, formerly Neukoplast)

Biological: aNK (NK-92)

aNK (NK-92) + N-803

EXPERIMENTAL

aNK (activated NK-92, formerly Neukoplast) and N-803

Biological: aNK (NK-92) + N-803

Interventions

aNK (NK-92) BIOLOGICAL

A natural killer cell line recovered from a patient with large granular lymphoma

Also known as: NK-92, Neukoplast

aNK (NK-92)

aNK (NK-92) + N-803 BIOLOGICAL

aNK - A natural killer cell line recovered from a patient with large granular lymphoma and N-803 - Recombinant human super agonist interleukin-15 (IL-15) complex

aNK (NK-92) + N-803

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years of age or older.
• Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging criteria for MCC. MCC of unknown primary is allowed.
• Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment will be required.
• ECOG performance status of 0-2.
• Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• Mandatory diagnostic biopsy and whole blood sample are required. The tumor biopsy tissue will be analyzed for the presence of immune cells and will also undergo genomic, transcriptomic, and proteomic profiling.

You may not qualify if:

• Major surgery within 30 days before study entry.
• Any of the following clinical laboratory values at the time of enrollment:
• Absolute neutrophil count (ANC) \< 1,000 cells/mm\^3.
• Platelets \< 50,000 x 10\^9/L.
• Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g. AST, ALT, GGT) \> 2 x the ULN. Elevation related to direct tumor infiltration is allowed.
• Renal insufficiency as indicated by a creatinine level \> 2 x the ULN.
• Myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the Investigator. Prior to study entry any known abnormality on an electrocardiogram (ECG) must be determined and documented by the Investigator to be not clinically significant to the patient participation in this study.
• Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
• Female patients who are pregnant or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
• Patients with other malignancies or brain metastasis are not eligible; however, given the frequent coexistence of MCC with other malignancies, the following exceptions are allowed:
• Patients who have been continuously disease-free for any solid tumor malignancy \>3 years prior to the time of enrollment.
• Patients with basal cell carcinoma or squamous cell carcinoma.
• Patients with prior history of in situ cancer (e.g., breast, melanoma, squamous cells carcinoma of the skin, cervical).
• Patients with prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy), but with undetectable PSA (\<0.2 ng/mL).
• Patients with chronic non-T-cell-based lymphocytic leukemia are eligible if they have isolated lymphocytosis (Rai stage O) on the condition that they do not require systemic treatment for their disease \["B" symptoms, Richter's transformation, lymphocyte doubling time (\<6 months) and they do not have lymphadenopathy of hepatosplenomegaly\].

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (3)

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

There is an insufficient number of subjects enrolled in order to evaluate efficacy.

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: September 24, 2015
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2020-08

Locations

US (3)