NCT03342417

Combination of Nivolumab and Ipilimumab in Breast, Ovarian and Gastric Cancer Patients

Terminated Phase 2 Last updated 9 November 2021

What this trial tests

Phase 2 trial testing Nivolumab in Breast Cancer Female in 5 participants. Terminated before completion.

Timeline

14 February 2018

Primary endpoint
29 May 2019

29 May 2019

Quick facts

Lead sponsor	ExcellaBio LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	14 February 2018
Primary completion	29 May 2019
Estimated completion	29 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Ipilimumab — full drug profile →

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Ovarian Cancer — all drugs for Ovarian Cancer →
• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

ExcellaBio LLC

Who can join

18 and older, any sex, with Breast Cancer Female or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Safety and tolerability of combination of Nivolumab and Ipilimumab will be studied in patients with 3 different types of cancers in 3 parts of the study, as shown below:

Part 1 - Neoadjuvant Therapy of Breast Cancer;

Part 2 - Therapy of Ovarian Cancer; and

Part 3 - Therapy of Gastric Cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic.
   Chan TA, Yarchoan M, Jaffee E, Swanton C, et al · · 2019 · cited 2009× · PMID 30395155 · DOI 10.1093/annonc/mdy495
2. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
3. PD-1/PD-L1 Targeting in Breast Cancer: The First Clinical Evidences Are Emerging. A Literature Review.
   Planes-Laine G, Rochigneux P, Bertucci F, Chrétien AS, et al · · 2019 · cited 162× · PMID 31336685 · DOI 10.3390/cancers11071033
4. Prognostic significance of tumor immune microenvironment and immunotherapy: Novel insights and future perspectives in gastric cancer.
   Lazăr DC, Avram MF, Romoșan I, Cornianu M, et al · · 2018 · cited 114× · PMID 30166856 · DOI 10.3748/wjg.v24.i32.3583
5. The Positive and Negative Immunoregulatory Role of B7 Family: Promising Novel Targets in Gastric Cancer Treatment.
   Bolandi N, Derakhshani A, Hemmat N, Baghbanzadeh A, et al · · 2021 · cited 69× · PMID 34639059 · DOI 10.3390/ijms221910719
6. Immunotherapy for HER2-positive breast cancer: recent advances and combination therapeutic approaches.
   Ayoub NM, Al-Shami KM, Yaghan RJ. · · 2019 · cited 69× · PMID 30697064 · DOI 10.2147/bctt.s175360
7. CAR-T Cell Therapy-An Overview of Targets in Gastric Cancer.
   Bębnowska D, Grywalska E, Niedźwiedzka-Rystwej P, Sosnowska-Pasiarska B, et al · · 2020 · cited 56× · PMID 32560392 · DOI 10.3390/jcm9061894
8. Breast Cancer Immunotherapy: An Update.
   Makhoul I, Atiq M, Alwbari A, Kieber-Emmons T. · · 2018 · cited 47× · PMID 29899661 · DOI 10.1177/1178223418774802