Personalized Vaccine With Immunotherapy for Triple Negative Breast Cancer

About the Study

This study is testing a personalized cancer vaccine designed using proteins identified 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 checkpoint inhibitors (drugs that help the immune system recognize and attack cancer), such as pembrolizumab or ipilimumab.

What the Study Involves

This study has two parts:

Part 1 (Phase 1A):
Participants receive the personalized vaccine alone at weeks 1, 3 and 5.

Part 2 (Phase 1B):
Participants receive the personalized vaccine in combination with a checkpoint inhibitor:

• One group receives pembrolizumab by IV at weeks 1, 3 and 5.
• One group receives ipilimumab 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