Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2

NCT05438498 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: ESR 22-21698
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 40

Brief Summary

If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk for infection and its sequelae are significantly increased. The Astra-Zeneca Immuno-Suppressed Program (AISP) is designed to address whether a patient treated for cancer who receives a single-dose of Evusheld (AZD7442) 600 mg IM or IV will maintain a stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death up to 12 months post-baseline. The program will focus on patients with cancer who have been treated with chemotherapy, immunotherapy, targeted therapy, other therapy or combination therapy with or without radiation therapy within 12 months prior to enrollment, are willing/able to receive one IM or IV injection of Evusheld, are able to complete 14 Patient Experience/Clinical Outcome Assessment (COA) surveys, 6 Quality of Life (QoL) assessments and are willing to allow serum concentrations of Evusheld to be drawn 9 times, 3 SARS-CoV-2 Receptor Binding Domain-Immunoglobulin G (RBD-IgG) tests, and T-cell assay to be drawn once. In the event of a symptomatic break-thru SARS-CoV-2 positive infection by SARS-COV-2 Ribonucleic Acid (RNA) by Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the patient will have an additional Evusheld serum concentration, SARS-CoV-2 RBD-IgG antibody level and T-cell assay obtained in a temporally related manner. The program requires treatment with Evusheld 600 mg IM or IV.

Conditions

SARS-CoV-2 Infection

Keywords

solid tumor; hematologic malignancy

Outcome Measures

Primary Outcomes (1)

• AZD7442 Serum Concentration

  The study's primary endpoint will assess AZD7442 serum concentration collected on days 30, 60, 90, 120 150, 180, 210, 270, and 360 post-baseline in all patients.

  12 months

Secondary Outcomes (2)

• Cancer Group and Treatment Group Comparison

  12 months

• SARS-CoV-2 Infection

  12 months

Study Arms (1)

Evusheld (AZD7442)

OTHER

Evusheld (tixagevimab+cilgavimab) 600 mg IM or IV administered one time only

Drug: Evusheld (tixagevimab+cilgavimab) IM or IV

Interventions

Evusheld (tixagevimab+cilgavimab) IM or IV DRUG

Evusheld (tixagevimab 300 mg +cilgavimab 300 mg) IM or IV

Also known as: AZD7442

Evusheld (AZD7442)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female gender at birth
• Age at least 18 years
• Women who are not pregnant, not breast feeding and of child bearing potential using contraception prior to enrollment in the study. Women of child bearing potential must agree to continued use of contraception throughout the 12 months of study participation.
• It is preferable that a patient has access to a "smartphone" or tablet or laptop or desktop computer and/or an email address
• In the event that a patient does not have access to any of the above, the patient may complete all follow-up surveys via the study's Call Center or in written form in the offices of the Principal Investigator as specified in the protocol
• Documented diagnosis of either hematologic malignancy or solid tumor as identified by standard ICD-10 diagnostic category
• Patients may be included with any ONE of the following criteria:
• On active treatment for solid tumor or hematologic malignancies. This can include: high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), as well as any FDA-approved alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) or any combination of these agents
• Hematologic malignancy patients can also be included if he/she is up to 12 months post-treatment and either in remission, stable or progressing as determined by the Investigator
• Solid tumor patients can also be included if he/she is up to 6 months post-treatment
• Received chimeric antigen receptor (CAR-T) or hematopoietic stem cell transplant (within 1 year of transplantation or taking immunosuppression therapy)
• Cancer is progressing as determined by the Investigator
• Treatment must have been initiated ≤12 months prior to baseline for all patients,
• Concomitant radiation therapy is permitted but cannot be the sole therapy
• Have been vaccinated with one or more doses of Janssen, Moderna or Pfizer COVID-19 vaccine

You may not qualify if:

• Women who are pregnant, breast feeding or of child bearing potential and not using contraception
• Absence of a qualifying type of cancer as defined by standard ICD-10 diagnostic criteria
• Treatment initiated \>12 months prior to baseline or were not on active therapy ≤12 months prior to enrollment with FDA approved oral, intramuscular and/or intravenous chemotherapy, immunotherapy, targeted therapy, other therapy or any combination of these agents
• Patient receiving only radiation therapy
• Patient with an ECOG performance status of 2 or higher
• Patient with an expected cancer survival of less than 12 months by disease category
• Patient receiving adjuvant endocrine therapy as their only form of therapy for early-stage breast cancer
• Solid tumor patients more than 6 months post treatment and their cancer is considered to be stable or in remission as determined by the Investigator
• AZD7442 IM administration at any time prior to day of enrollment
• AZD7442 IM or IV administration on the same day as the patient receives any IV or IM cancer treatment
• Have a positive test for SARS-CoV-2 antigen performed by either Rapid Test or SARS-CoV-2 RNA by RT-PCR (Polymerase Chain Reaction) less than 90 days prior to enrollment
• Patient with a prior (within 90 days), current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any other EUA approved SARS-CoV-2 treatment
• Patient with fever \>100.0 F, and/or cough, chills, loss of smell or taste or shortness of breath or any other signs or symptoms consistent with COVID-19 within 5 days prior to enrollment
• Patient who has any known active acute respiratory infection
• Patient who has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection

Sponsors & Collaborators

• MediMergent, LLC: lead

Study Sites (40)

Compassionate Cancer Care Medical Group

Corona, California, 92879, United States

Location

Compassionate Care Medical Group

Fountain Valley, California, 92708, United States

Location

Ventura County Hematology Oncology

Oxnard, California, 93030, United States

Location

Compassionate Cancer Care Medical Group

Riverside, California, 92501, United States

Location

Cancer Center of Southern California

Santa Monica, California, 90403, United States

Location

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, 06360, United States

Location

South Florida Cancer Care

Margate, Florida, 33063, United States

Location

Florida Cancer Affiliates-Ocala

Ocala, Florida, 34474, United States

Location

Mid-Florida Hematology Oncology Center

Orange City, Florida, 32763, United States

Location

Comprehensive Hematology Oncology

St. Petersburg, Florida, 33709, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

Mary Bird Perkins

Baton Rouge, Louisiana, 70809, United States

Location

Maryland Oncology Hematology

Annapolis, Maryland, 21401, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Maryland Oncology Hematology

Bethesda, Maryland, 20817, United States

Location

Maryland Oncology Hematology

Brandywine, Maryland, 20613, United States

Location

Maryland Oncology Hematology

Columbia, Maryland, 21044, United States

Location

Maryland Oncology Hematology

Lanham, Maryland, 20706, United States

Location

Maryland Oncology Hematology

Rockville, Maryland, 20850, United States

Location

Maryland Oncology Hematology

Silver Spring, Maryland, 20904, United States

Location

Health Partners Institute-MMORC

Saint Louis Park, Minnesota, 55426, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

New Jersey Center for Cancer Research

Brick, New Jersey, 08724, United States

Location

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Minniti Center for Oncology and Hematology

Mickleton, New Jersey, 08056, United States

Location

Southeastern Medical Oncology Center

Jacksonville, North Carolina, 28546, United States

Location

Regional Medical Oncology Center

Wilson, North Carolina, 27893, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

Location

Alliance Cancer Specialists

Bensalem, Pennsylvania, 19020, United States

Location

Consultants in Medical Oncology Hematology

Broomall, Pennsylvania, 19008, United States

Location

Pennsylvania Cancer Specialists and Research Institute

Gettysburg, Pennsylvania, 17325, United States

Location

Alliance Cancer Specialists

Horsham, Pennsylvania, 19044, United States

Location

Alliance Cancer Specialists

Langhorne, Pennsylvania, 19047, United States

Location

Alliance Cancer Specialists

Philadelphia, Pennsylvania, 19115, United States

Location

Alliance Cancer Specialists

Sellersville, Pennsylvania, 18960, United States

Location

Alliance Cancer Specialists

Wynnewood, Pennsylvania, 19096, United States

Location

Tidelands Health Oncology

Murrells Inlet, South Carolina, 29576, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

Summit Cancer Centers

Spokane Valley, Washington, 99216, United States

Location

MeSH Terms

Conditions

COVID-19; Hematologic Neoplasms

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ralph Boccia, MD

  Center for Cancer and Blood Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multi-center, prospective, open-label, pragmatic evaluation

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 30, 2022
• Study Start: June 3, 2022
• Primary Completion: April 29, 2023
• Study Completion: June 30, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

US (40)