Brief Summary

Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started May 2015

Longer than P75 for phase_1

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

November 26, 2014

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

May 5, 2015

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed

Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

4.5 years

First QC Date

November 26, 2014

Last Update Submit

January 12, 2023

Conditions

Melanoma

Keywords

melanomaipilimumabcoxsackievirus A21CAVATAKCVA21checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

Response
Best response of complete response (CR) or partial response (PR)
106 days

Secondary Outcomes (3)

DRR
lasting 26 weeks or longer
PFS
At 6 and 12 months
OS
Through study completion, an average of 2 years

Study Arms (1)

CAVATAK and ipilimumab

EXPERIMENTAL

CAVATAK intratumoral injection up to a total dose of 3 x 10⁸ TCID50 and ipilimumab intravenously at the recommended dose of 3 mg/kg

Biological: CAVATAKDrug: Ipilimumab

Interventions

CAVATAKBIOLOGICAL

CAVATAK is a preparation of CVA21

Also known as: Coxsackievirus A21, CVA21

CAVATAK and ipilimumab

IpilimumabDRUG

Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma

Also known as: Yervoy®

CAVATAK and ipilimumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with unresectable or metastatic stage III B/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on prior anti-PD-1 therapy, according to RECIST 1.1 criteria. Patients who progressed within 3 months of treatment start are excluded.
Patients must have at least one cutaneous or subcutaneous tumor, measuring 0.5 to 5.0 cm in the longest diameter, or a palpable lymph node. At least one tumor must qualify as an index lesion that can be accurately and reproducibly measured in two dimensions for which the longest diameter is .10 mm (.15 mm in short axis diameter \[SAD\] for lymph nodes), and be amenable to intratumoral injection.
Histological confirmation of melanoma will be required by previous biopsy or cytology.
Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
Patients with ≤ 3 visceral metastases (excluding pulmonary lesions), with no lesions \>3.0 cm. Patients with substantial tumor burden of non-measurable disease may not be good candidates for an immunotherapy and should be discussed with the Medical Monitor.
\. ECOG performance status of 0-1.

You may not qualify if:

Patients with tumors to be injected lying close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigator, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. Patients with lesions in mucosal areas (vulvar, anus, oral cavity, etc.), are eligible, as long as the subject has at least one lesion suitable for injection; consult Medical Monitor for confirmation.
Patients with active, known or suspected autoimmune disease except for autoimmune thyroiditis or vitiligo. Thyroiditis patients must be asymptomatic, on adequate thyroid replacement and have normal thyroid function tests.
Patients with active colitis or immune-mediated colitis that has not resolved to grade 1 or less.
Patients with untreated brain metastases. Patients with treated brain metastases who are off corticosteroids for at least two weeks and who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
Patients previously treated with CVA21.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Viralyticslead
Providence Health & Servicescollaborator

Study Sites (11)

City of Hope National Medical Center,

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

The Angeles Clinic & Research Institute

Los Angeles, California, 90025, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Advocate Health, SC

Park Ridge, Illinois, 60068, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Atlantic Melanoma Center

Morristown, New Jersey, 07960, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

Curti BD, Richards J, Hyngstrom JR, Daniels GA, Faries M, Feun L, Margolin KA, Hallmeyer S, Grose M, Zhang Y, Li A, Andtbacka RHI. Intratumoral oncolytic virus V937 plus ipilimumab in patients with advanced melanoma: the phase 1b MITCI study. J Immunother Cancer. 2022 Dec;10(12):e005224. doi: 10.1136/jitc-2022-005224.
PMID: 36564126RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

Brendan Curti, MD
Providence Health & Services
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 4, 2014

Study Start

May 5, 2015

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing: Will share

Locations

US(11)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

CAVATAK and ipilimumab

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations