Dose Escalation Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies

Description

This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma

Study Start Date

August, 09 2017

Estimated Completion Date

July 2019

Interventions

  • Biological: mRNA-2416

Study ID

Moderna Therapeutics -- mRNA-2416-P101

Status

Recruiting

Trial ID

NCT03323398

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

75

Sponsor

Moderna Therapeutics

Inclusion Criteria

  • Written informed consent prior to completing any study-specific procedure
  • Histologically
  • or cytologically-confirmed advanced/metastatic solid tumor or lymphoma that is refractory to standard therapies, or the patient refuses standard therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ? 2
  • Adequate hematological and biological function
  • Female patients of childbearing potential must have a negative serum pregnancy test
  • Male and female patients must agree to use a highly reliable method of birth control.

Exclusion Criteria

  • Active central nervous system tumors or metastases
  • Treatment with prohibited medications (eg, concurrent anti-cancer therapy including other chemotherapy, radiation (local radiation for palliative care is permitted), hormonal anti-cancer treatment, biologic therapy, or immunotherapy) < 28 days prior to the first day of study treatment
  • Active or prior autoimmune disorder within the past 2 years
  • History of primary immunodeficiency, solid organ transplantation, or tuberculosis
  • Any plan to receive a live attenuated vaccine during study treatment
  • History of human immunodeficiency virus infection (testing is not required)
  • Active/chronic hepatitis B or C
  • Females who are pregnant or breastfeeding

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles None None None
Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
University of Minnesota Medical Center - Minneapolis, Minnesota 1,120.0 miles None None None
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles None None None
Huntsman Cancer Institute - Salt Lake City, Utah 2,094.1 miles None None None
Mayo Clinic - Phoenix, Arizona 2,284.5 miles None None None

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