Personalized Vaccine With Immunotherapy for Early-Stage or Metastatic Triple Negative Breast Cancer

About the Study

This study is testing a personalized cancer vaccine designed using proteins taken from a person’s tumor. The goal of the study is to evaluate the safety of the vaccine, determine the best dose, and understand how the immune system responds when the vaccine is given alone or in combination with immunotherapy drugs. The study is open to people with early-stage breast cancer and people with metastatic breast cancer. 

What the Study Involves

This study will be conducted in two phases:

Phase 1A

Phase 1A will enroll only people with early-stage breast cancer. All participants who enroll in Phase 1A will receive the personalized vaccine as an injection into the skin at weeks 1, 3 and 5.

Phase 1B:

Phase 1B will enroll people with early-stage or metastatic breast cancer. All participants who enroll in Phase 1B will receive the personalized vaccine as an injection into the skin at weeks 1, 3 and 5.

in combination with a checkpoint inhibitor:

• One group receives pembrolizumab (Keytruda) by IV at weeks 1, 3 and 5.
• One group receives ipilimumab (Yervoy) by IV on day 1 and then again every 21 days for 6-9 cycles. 

Treatment continues for a defined period or until side effects or cancer progression require stopping.

After treatment is completed, participants are followed approximately every 12 weeks for up to 2 years.

People who meet the following criteria:

• Age 18 or older
• Diagnosed with triple negative breast cancer (TNBC), including:
  • Early-stage (Stage I–III) or
  • Locally advanced or metastatic disease
• Have completed standard treatment (such as chemotherapy, radiation, or immunotherapy), with required waiting periods
• Have enough tumor tissue available to create a personalized vaccine
• Are able to carry out most daily activities
• Have adequate blood, kidney, and liver function
• Are willing to have tumor testing performed to help design the personalized vaccine

• People who do not have enough tumor tissue available to create the vaccine
• People with serious or uncontrolled medical conditions, such as:
  • Recent heart attack or significant heart disease
  • Serious abnormal heart rhythms
  • Active, uncontrolled infections
• People with another cancer within the past 5 years (with some exceptions, such as certain skin cancers)
• People currently receiving other cancer treatments without required waiting periods
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study
• People with active or untreated cancer that has spread to the brain or central nervous system
• People with a weakened immune system or taking significant immune-suppressing medications (with some exceptions)
• People with active autoimmune disease requiring treatment in the past 2 years
• People with a history of severe lung inflammation (pneumonitis) requiring steroids
• People who have not recovered from serious side effects of prior cancer treatment
• People who previously had severe side effects from immunotherapy