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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05311176




Registration number
NCT05311176
Ethics application status
Date submitted
8/03/2022
Date registered
5/04/2022
Date last updated
29/02/2024

Titles & IDs
Public title
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
Scientific title
nextHERIZON: An Open-Label, Signal Generating, Phase 2 Study of HER-Vaxx in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric or Gastroesophageal Junction (GEJ) Adenocarcinomas Who Have Previously Received Trastuzumab and Progressed on This Treatment
Secondary ID [1] 0 0
IMU.131.203
Universal Trial Number (UTN)
Trial acronym
nextHERIZON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Cancer of Stomach 0 0
Gastric Adenocarcinoma 0 0
Stomach Cancer 0 0
Stomach Adenocarcinoma 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IMU-131
Treatment: Drugs - Ramucirumab plus Paclitaxel
Other interventions - Pembrolizumab

Experimental: Arm 1: HER-Vaxx in combination with chemotherapy (ramucirumab plus paclitaxel) - Patients who have received an immune checkpoint inhibitor (ICI) previously will exclusively be enrolled in Arm 1 treated with HER-Vaxx (IM) in combination with chemotherapy (ramucirumab plus paclitaxel)

Experimental: Arm 2: HER-Vaxx in combination with pembrolizumab - Arm 2 will investigate the combination of HER-Vaxx plus pembrolizumab in patients who are naïve to ICI treatment including patients who have had chemotherapy only treatment after progression on trastuzumab. As the combination treatment has not been investigated, Arm 2 is planned to initiate with a safety run-in phase.


Other interventions: IMU-131
IMU-131 will be administered intramuscularly into the deltoid region of the arm on Day 1, 15, 29 and 57 and then every 63 days until disease progression or treatment discontinuation.

Treatment: Drugs: Ramucirumab plus Paclitaxel
Chemotherapy to be administered every 3 weeks (Q3W) starting on Day 1.

Other interventions: Pembrolizumab
Pembrolizumab will be administered every 3 weeks (Q3W) starting on Day 1 until disease progression or treatment discontinuation.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and Severity of Treatment-Emergent Adverse Events [safety and tolerability] of HER-Vaxx in combination with chemotherapy or pembrolizumab
Timepoint [1] 0 0
From date of enrollment through study completion, an average of 6 months
Primary outcome [2] 0 0
Objective Response Rate of HER-Vaxx in combination with chemotherapy or pembrolizumab
Timepoint [2] 0 0
From date of enrollment until the date of first documented progression or date of death from any cause, an average of 6 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of enrollment until the date of death from any cause, an average of 1 year
Secondary outcome [2] 0 0
Progression Free Survival
Timepoint [2] 0 0
From date of enrollment until the date of first documented progression or date of death from any cause, an average of 6 months
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
From date of earliest CR or PR until the date of first documented progression or date of death from any cause, an average of 3 months

Eligibility
Key inclusion criteria
1. Age = 18 years with confirmed diagnosis of advanced or metastatic HER2/neu
overexpressing gastric or GEJ adenocarcinoma;

2. Progressed on or after trastuzumab therapy;

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

4. Life expectancy of a minimum of 3 months;

5. At least one measurable lesion as defined by RECIST 1.1 criteria and assessed by the
local investigator;

6. HER2/neu overexpression assessed using post-progression fresh or archival tissue, or
post-progression pathology report;

7. Adequate left ventricular ejection function at baseline, defined as left ventricular
ejection fraction (LVEF) > 50% by echocardiogram or Multi Gated Acquisition (MUGA)
scan;

8. Adequate hematologic, liver and renal function;

9. A female patient of childbearing potential must agree to use a highly effective method
of contraception throughout the study and for at least 120 days after the last dose of
assigned treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous malignant disease (other than primary malignancy) within the last 5 years,
except basal or squamous cell carcinoma of the skin or cervical carcinoma in situ;

2. Concurrent active malignancy except for adequately controlled limited basal cell
carcinoma of the skin;

3. Systemic chemotherapy or major surgery within 28 days before starting study treatment
and recovered from all adverse events = Grade 1 or baseline with possible exceptions
for neuropathy and endocrine-related AEs;

4. Received prior radiotherapy within 2 weeks of start of study treatment and recovered
from all radiation-related toxicities and not require corticosteroids; or history of
radiation pneumonitis.

5. Previous treatment with trastuzumab-deruxtecan or any other anti-HER2 therapy (except
trastuzumab);

6. Clinically significant cardiovascular disease, or other diseases that in the
Investigator's opinion may influence the patient's tolerance to study treatment;

7. Pleural effusion or ascites requiring more than weekly drainage;

8. Prior organ transplantation, including allogenic stem-cell transplantation;

9. Chronic immunosuppressive therapy within 7 days prior the first dose of study drug;

10. Active, known, or suspected autoimmune disease;

11. History of (non-infectious) pneumonitis / interstitial lung disease that required
steroids or has current pneumonitis / interstitial lung disease;

12. Positivity for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active
hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA]
qualitative) infection;

13. Current participation or has participated in a study of an investigational agent or
has used an investigational device within 4 weeks prior to the first dose of study
treatment;

14. Any vaccination within 30 days prior to starting study treatment;

15. Pregnant or lactating females;

16. Arm 2 only: Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent;

17. Arm 2 only: Has received prior therapy with an ICI or with an agent directed to
another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and
was discontinued from treatment due to a grade 3 or higher adverse event.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Kaohsiung City
Country [2] 0 0
Taiwan
State/province [2] 0 0
Tainan City
Country [3] 0 0
Taiwan
State/province [3] 0 0
Taipei
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Imugene Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 2, signal generating, open-label, 2-Arm, non-randomized study, in patients
with metastatic HER2/neu over-expressing gastric cancer or gastroesophageal adenocarcinomas.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05311176
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries