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Cancer Vaccine

Viral Therapy for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable by CT with IV contrast as follows: Chest x-ray ≥ 20 mm, CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm (Longest diameter), Physical exam (using calipers) ≥ 10 mm, Lymph nodes by CT scan ≥ 15 mm (Measured in short axis). All radiology studies must be performed within 14 days prior to registration (within 21 days if negative). Patients must have at least one additional tumour mass amenable to core needle or excisional biopsy that is not a measurable lesion that will be used as a target lesion. Patients must consent to and be willing and able to undergo at least two core needle biopsies of that lesion. Age ≥ 18 years, ECOG performance status of 0 or 1, Patients must have received at least one prior standard first line regimen for advanced or metastatic disease. The regimen may have been cytotoxic chemotherapy, targeted therapy, hormonal therapy (e.g. anastrozole) or immunotherapy providing considered a standard first line therapy. There is no limit to the number of prior regimens but investigators and their patients should carefully consider the likelihood of benefit of an immunologic therapy in heavily pretreated patients. For phase II, patients may be enrolled prior to disease progression, provided they have completed their first line therapy as below and they have documented stable disease on two consecutive tumour assessments (i.e. do not have evidence of tumour regression from therapy): NSCLC patients may be entered after a minimum of 4-6 cycles of first line combination chemotherapy; if the patient is >70 years a single agent regimen is acceptable. If the patient has documented EGFR or ALK mutations, treatment they may have received may include an EGFR inhibitor or ALK inhibitor as first line therapy. Breast cancer patients may be entered after a minimum of 6 cycles of first line therapy. Patients with metastatic/recurrent esophageal carcinoma may be entered after first line chemotherapy for metastatic disease. Washout period between last day of prior treatment and planned start of treatment is the longest of one of the following: two weeks, standard cycle length of prior regimen, 10 half-lives for investigational drugs, 30 days since last dose of ipilumumab or PR1/PDL1 therapy. Patients must have recovered from any treatment related toxicities prior to registration (unless grade 1, irreversible and considered not clinically significant). Progression must be documented post radiotherapy if was given to the only site of measurable disease. Patients may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Patients must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant). Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred. Laboratory requirements done within 7 days prior to registration: WBC ≥ 3.0 x 10^9/L, absolute neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, INR ≤ 1.2, bilirubin ≤ 1.5 x UNL (upper normal limit), AST and ALT ≤ 3.0 x UNL or ≤ 5.0 x UNL if patient has liver metastases, serum creatinine ≤ 1.5 x UNL or creatinine clearance ≥ 60ml/min, serum phosphate > 0.8mMol/L (grade 0-1), Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to registration and prior to tests which are considered to be study specific, Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested, Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre, Pre-treatment biopsy must be done within 5 working days after registration and treatment is to begin within 5 working days of the pre-treatment biopsy (max. 10 working days from registration).

PHASE I: Patients must have histologically confirmed, unresectable locally advanced/metastatic solid tumour with positive expression of MAGE-A3 (primary or metastatic lesion) and for which there is no known life prolonging standard therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination of three viruses can help treat cancer by shrinking tumours. The viruses are given one after the other, with the AdMA3 virus given first. It is not known if this treatment will be more effective than standard cancer treatments.

Who is the study for?

Adults with certain advanced solid tumors expressing MAGE-A3, who've had at least one standard treatment. They must have measurable disease and be in good physical condition (ECOG 0 or 1). Excluded are those with active infections, other cancers needing treatment, significant medical issues, brain metastases requiring steroids, or pregnant/breastfeeding individuals.

What is being tested?

The trial is testing two viruses: MG1MA3 alone or followed by AdMA3. These have shown promise in killing cancer cells and boosting immune response against the tumor antigen they carry. The study aims to see if this approach works better than standard treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's activation such as flu-like symptoms, fatigue, fever, and possibly inflammation around the body due to an enhanced immune response targeting both cancerous and healthy tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is advanced, cannot be surgically removed, and tests positive for MAGE-A3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Toxicity as measured by adverse events

Phase II: Objective tumour response rate (ORR) using RECIST v1.1.

Secondary study objectives

Phase I: Cellular and humoral immune response to virus and tumour antigens

Phase I: Delivery to, and viral detection and replication within, tumours for MG1MA3

Phase I: Efficacy using RECIST v1.1 and iRECIST

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C- AdMA3 plus MG1MA3 (prime + boost)Experimental Treatment2 Interventions

Prime AdMA3 vaccine will be administered as a single dose of 1x10\^10 pfu IM at day (-14) followed by dose escalation of MG1MA3 boost, IV administered on days 1 \& 4 at a starting dose of 1 log below the recommended phase II dose (RP2D), as determined in Arm A of this study. MG1MA3 dose will be escalated as defined in protocol.

Group II: Arm B- AdMA3 (vaccine prime) aloneExperimental Treatment1 Intervention

Six patients will receive prime AdMA3 vaccine at a dose of 1x10\^10 pfu administered IM on day (-14). No dose escalation is planned.

Group III: Arm A (MG1MA3 virus alone)Experimental Treatment1 Intervention

The starting dose of MG1MA3 will be 1 x 10\^10 pfu administered by IV on day 1 and day 4.MG1MA3 dose will be escalated as per protocol.

0 / 2Eligibility criteria met