A Study of Experimental INCMGA00012 For Squamous Carcinoma of the Anal Canal After Platinum-Based Chemotherapy

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Squamous Carcinoma, Squamous Carcinoma of the Anal Canal, cancer of the anal canal
Type: Drug study, Phase 2
Target:
5 Participants
Investigator:
Description
You are being asked to take part in this research study because you have anal cancer. Your cancer has not responded to platinum-based chemotherapy.

This study will test whether INCMGA00012 is safe and effective to treat Squamous Carcinoma of the Anal Canal (SCAC). SCAC is a rare cancer of the digestive system that can spread rapidly to other areas of the body. Immunotherapy is a new approach to treatment in advanced SCAC. In this study you and all other participants will receive INCMGA00012.

INCMGA00012 is an experimental drug that is being studied for use in the treatment of Squamous Carcinoma of the Anal Canal (SCAC). “Experimental” means that INCMGA00012 has not been approved by the FDA.

INCMGA00012 is designed to activate the immune system.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Ability to comprehend and willingness to sign a written informed consent form.
  • Confirmed diagnosis of locally advanced or metastatic SCAC.
  • Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
  • Must have measurable disease by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

Exclusion criteria:

  • Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
  • Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
  • Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
  • Active autoimmune disease requiring systemic immunosuppression.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known active hepatitis infection.
  • Active infections requiring systemic therapy.
  • Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You may receive treatment with this study drug up to 2 years during which time you cannot participate in other research studies. Your total participation in this study could last up to about 3 years.
Recruitment period
From Feb. 12, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Squamous Cell Carcinoma of Anal Canal