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Cancer Vaccine

Cisplatin for Breast Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment, if considered safe by the Investigator
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new combination therapy for subjects with TNBC who have progressed after previous SoC chemotherapy. The safety and efficacy of the therapy will be evaluated in two stages.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You need to be okay with giving a small piece of your tumor for testing 8 weeks after starting treatment, as long as it's safe to do so according to the doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months) by RECIST and irRC.
Duration of response by RECIST and irRC
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
+8 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: NANT triple negative breast cancer (TNBC) VaccineExperimental Treatment18 Interventions
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
5-Fluorouracil
2012
Completed Phase 3
~7800
Leucovorin
2005
Completed Phase 4
~5730
N-803
2021
Completed Phase 2
~50
Cyclophosphamide
1995
Completed Phase 3
~3780
ETBX-011
2017
Completed Phase 2
~10
bevacizumab
2002
Completed Phase 3
~3360
avelumab
2021
Completed Phase 3
~1170
GI-4000
2006
Completed Phase 2
~180
Capecitabine
2013
Completed Phase 3
~3420
SBRT
2014
Completed Phase 2
~1060
nab-Paclitaxel
2014
Completed Phase 3
~7680

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
60 Previous Clinical Trials
5,024 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently open for this investigation?

"According to clinicaltrials.gov, this particular study is no longer recruiting participants, having initially been posted on March 16th 2018 and last updated on the 28th of March 2022. Nonetheless, there are 5148 other trials actively enrolling patients at this moment in time."

Answered by AI

What medical conditions are commonly treated with Cisplatin?

"Cisplatin is a well-regarded therapy for macrocytic anemia and has seen success in treating neoplasm metastasis, recurrent cervical cancer, and leukemias."

Answered by AI

How many people are actively participating in this experimentation?

"Unfortunately, no new participants are currently being sought for this clinical trial. It was initially posted on March 16th 2018 and last updated on the 28th of March 2022. However, there are many other studies recruiting individuals with triple negative breast neoplasms (2351) or Cisplatin-related issues (2797)."

Answered by AI

What prior experiments have been done utilizing Cisplatin?

"Currently, there are over two thousand studies underway to investigate Cisplatin; of these trials, 727 have advanced to Stage 3. Guangzhou and Guangdong in China host numerous clinical trials for this drug with 117505 other locations around the world conducting research as well."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Chan Soon-Shiong Institute for Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Mar 2025