5 Participants Needed

Combo Immunotherapy for Triple Negative Breast Cancer

SG
Overseen ByShipra Gandhi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.

Will I have to stop taking my current medications?

The trial requires that you stop any cancer-directed therapy at least 3 weeks before starting the study treatment. If you are on systemic immunosuppressive agents, including certain steroids, you must stop them 3 weeks before joining the trial. Inhaled steroids are allowed.

Is the combo immunotherapy for triple-negative breast cancer safe?

Pembrolizumab, a part of the combo immunotherapy, can cause immune-related side effects in some patients, such as inflammation in different parts of the body. In studies, these side effects were seen in about 64% of patients, with 20% experiencing more severe reactions. It's important to monitor and manage these side effects during treatment.12345

What makes the Combo Immunotherapy for Triple Negative Breast Cancer unique?

This treatment is unique because it combines multiple immunotherapy agents, including Celecoxib, Interferon Alpha-2, Pembrolizumab, and Rintatolimod, which work together to enhance the body's immune response against cancer cells. Unlike standard chemotherapy, this combination aims to boost the immune system's ability to fight cancer, potentially offering a novel approach for patients with triple-negative breast cancer.26789

What data supports the effectiveness of the drug pembrolizumab in treating triple-negative breast cancer?

Research shows that pembrolizumab, when combined with chemotherapy, significantly improved outcomes for patients with high-risk, early-stage triple-negative breast cancer, leading to FDA approval based on better response rates and survival compared to chemotherapy alone.28101112

Who Is on the Research Team?

EL

Ellis Levine, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. They must have normal bilirubin levels, agree to use contraception, and not have had cancer treatment in the last 3 weeks. Patients should be able to take oral meds, have measurable disease, and a performance status indicating they are relatively active.

Inclusion Criteria

My cancer has worsened despite previous treatments.
My kidney function, measured by creatinine levels, is normal or near normal.
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
See 13 more

Exclusion Criteria

Pregnant or nursing female participants
I have had stomach ulcers, bleeding, or a hole in my stomach in the last 3 years.
I am allergic to NSAIDs or any medication planned for this treatment.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive rintatolimod, celecoxib, and interferon alpha-2b, followed by pembrolizumab. Treatment includes IV and oral administration over a 2-week cycle, with pembrolizumab every 3 weeks.

6-8 weeks
Multiple visits (in-person) for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT/MRI scans and blood sample collection.

Up to 2 years
Regular visits (in-person) for imaging and sample collection

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to assess long-term safety and efficacy.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Celecoxib
  • Interferon Alpha-2
  • Pembrolizumab
  • Rintatolimod
Trial Overview The trial tests chemokine modulation therapy (CKM) - rintatolimod with celecoxib and interferon alpha 2b - combined with pembrolizumab immunotherapy. CKM may modify immune responses and tumor growth while pembrolizumab could help the immune system fight cancer more effectively.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort II (CMK, early pembrolizumab)Experimental Treatment8 Interventions
Group II: Cohort I (CKM, pembrolizumab)Experimental Treatment7 Interventions

Celecoxib is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Celebrex for:
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Approved in European Union as Celebrex for:
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Approved in Canada as Celebrex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pembrolizumab, an anti-PD-1 monoclonal antibody, has been shown to significantly improve treatment outcomes for high-risk, early-stage triple-negative breast cancer (TNBC) when combined with standard chemotherapy, leading to a marked increase in pathologic complete response rates and 3-year event-free survival, as demonstrated in the KEYNOTE-522 trial.
The FDA approved pembrolizumab in July 2021, marking a significant shift in the treatment approach for TNBC, which has historically been challenging due to its aggressive nature and limited targeted therapies.
Targeted Treatment for High-Risk Early-Stage Triple-Negative Breast Cancer: Spotlight on Pembrolizumab.Bagegni, NA., Davis, AA., Clifton, KK., et al.[2023]
In the KEYNOTE-086 study involving 254 patients with metastatic triple-negative breast cancer, several biomarkers such as PD-L1, CD8, stromal tumor-infiltrating lymphocytes (sTILs), tumor mutational burden (TMB), and T-cell-inflamed gene expression profile (TcellinfGEP) were significantly associated with better clinical outcomes when treated with pembrolizumab.
These findings suggest that assessing these biomarkers can help identify which patients are more likely to benefit from pembrolizumab monotherapy, enhancing personalized treatment strategies for metastatic triple-negative breast cancer.
Association Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis.Loi, S., Salgado, R., Schmid, P., et al.[2023]
In a phase 3 trial involving 902 patients with metastatic triple-negative breast cancer, the combination of atezolizumab and nab-paclitaxel showed a median overall survival of 21.0 months compared to 18.7 months with placebo, although this difference was not statistically significant in the overall population.
For patients with PD-L1 immune cell-positive tumors, atezolizumab plus nab-paclitaxel demonstrated a significant overall survival benefit, with a median survival of 25.0 months versus 18.0 months for placebo, highlighting its potential as an important treatment option for this subgroup.
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial.Schmid, P., Rugo, HS., Adams, S., et al.[2020]

Citations

Targeted Treatment for High-Risk Early-Stage Triple-Negative Breast Cancer: Spotlight on Pembrolizumab. [2023]
Association Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis. [2023]
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. [2020]
Q-TWiST analysis of pembrolizumab combined with chemotherapy as first-line treatment of metastatic triple-negative breast cancer that expresses PD-L1. [2023]
Investigating potential immune mechanisms of trilaciclib administered prior to chemotherapy in patients with metastatic triple-negative breast cancer. [2023]
Emergence of immune-related adverse events correlates with pathological complete response in patients receiving pembrolizumab for early triple-negative breast cancer. [2023]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Managing adverse effects of immunotherapy. [2018]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Neoadjuvant Pembrolizumab Takes on TNBC. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Atezolizumab Combo Approved for PD-L1-positive TNBC. [2020]
Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041). [2023]
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