This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers

Age Range:18 - Any
Start Date:June 21, 2018
End Date:June 2022
Contact:Tara Hollister - Clinical Trial Assistant

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Phase 1/1b, Multicenter, Open-label Trial of Oncolytic MG1 Virus (MG1-E6E7) With Adenovirus Vaccine (Ad-E6E7) Both Expressing Mutant Human Papilloma Virus (HPV) E6 and E7 and Atezolizumab in Pts With HPV Assoc. Cancers

This is a Phase 1/1b open-label dose escalation trial of Ad/MG1-E6E7 and sequential treatment
with atezolizumab in patients with HPV associated cancers. This study will consist of two
arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish
initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD).

- Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7
priming and subsequent treatment with IV atezolizumab.

- Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming
and subsequent treatment with IV atezolizumab.

In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as
determined in Phase 1 in order to more thoroughly explore immune response,
pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV
positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+
tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).

Key Inclusion Criteria:

- Histologically or cytologically confirmed recurrent or metastatic HPV associated tumor
(cervical, oropharyngeal, vulvar, vaginal, anal, or penile) with documented disease

- Arm 1, Phase 1 dose escalation: Cervical, HPV+ oropharyngeal, vulvar, vaginal, anal,
or penile

- Arm 1, Cohort A: Cervical cancer

- Arm 1, Cohort B: HPV+ Oropharyngeal cancer

- Arm 2 Phase 1 dose escalation and Cohort C: Cervical, oropharyngeal, vulvar, vaginal,
anal, or penile

- Failed, refused or intolerant to systemic therapy

- Measurable disease based on RECIST 1.1

- At least one tumor mass amenable to core needle biopsy

- Arm 2 only: At least one tumor judged as being safely injectable

- ECOG performance status 0 or 1

- Demonstrate adequate organ function

- Additional Inclusion criteria exist

Key Exclusion Criteria:

- Prior systemic therapy within 4 weeks.

- Patients receiving prior XRT must have recovered from any acute toxicity.

- Currently receiving/received experimental therapy within 4 weeks.

- Prior treatment with any HPV vaccine therapy for cancer.

- Requires use of anti-platelet or anti-coagulant therapy that cannot be safely
suspended for per protocol biopsies or intra-tumoral injections.

- Known active CNS metastases and/or carcinomatous meningitis.

- Clinically significant tumor invasion/ rapidly accumulating ascites, pericardial or
pleural effusions.

- Active infection requiring systemic therapy.

- Active autoimmune disease that has required systemic therapy in the past 2 years.

- Conditions likely to have resulted in splenic dysfunction.

- Known HIV/AIDS, active HBV or HCV infection.

- Received prior treatment with vesicular stomatitis (VSV) viral vector.

- Received immunosuppressive medication within 4 weeks. (>10mg/day prednisone)

- ≥ Grade 2 dyspnea and/or require supplemental oxygen

- Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy

- Additional Exclusion criteria exist

Exclusion Criteria Household Contacts:

- Patients with household contacts meeting any of the following criteria are ineligible
for study entry unless alternate living arrangements can be made, while under contact

- Women who are pregnant or nursing an infant

- Children < 1 year old

- Individuals who are severely immunocompromised

- Contact precautions are from initial treatment with MG1-E6E7 to 7 days after the last
dose of MG1-E6E7
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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801 North 29th Street
Billings, Montana 59107
Phone: 406-435-7443
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
Billings, MT
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Hamilton, Ontario
Principal Investigator: Sebastien Hotte, MD
Phone: 905-387-9711
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1515 Holcombe Blvd
Houston, Texas 77030
Principal Investigator: Bonnie Glisson, MD
Phone: 713-745-9919
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Houston, TX
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Dmitriy Zamarin, MD
Phone: 646-888-5097
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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Toledo, Ohio 43614
Principal Investigator: John Nemunaitis, MD
Phone: 419-383-6962
Toledo, OH
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