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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03625323




Registration number
NCT03625323
Ethics application status
Date submitted
16/07/2018
Date registered
10/08/2018
Date last updated
19/07/2019

Titles & IDs
Public title
Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC
Scientific title
TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)
Secondary ID [1] 0 0
Keynote-PN798
Secondary ID [2] 0 0
TACTI-002
Universal Trial Number (UTN)
Trial acronym
TACTI-002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
HNSCC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eftilagimod alpha
Treatment: Drugs - Pembrolizumab

Experimental: 1st line NSCLC - Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.

Experimental: 2nd line NSCLC - Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.

Experimental: HNSCC - Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.


Treatment: Drugs: Eftilagimod alpha
APC activator, MHC II agonist, LAG-3 fusion protein

Treatment: Drugs: Pembrolizumab
anti-PD-1 antibody

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of objective response rate (ORR) according to iRECIST
Timepoint [1] 0 0
up to 24 month
Secondary outcome [1] 0 0
Duration of (serious) adverse events
Timepoint [1] 0 0
up to 24 month
Secondary outcome [2] 0 0
Frequency of (serious) adverse events
Timepoint [2] 0 0
up to 24 month
Secondary outcome [3] 0 0
Severity of (serious) adverse events
Timepoint [3] 0 0
up to 24 month
Secondary outcome [4] 0 0
Time to responses according to iRECIST and RECIST 1.1
Timepoint [4] 0 0
up to 24 month
Secondary outcome [5] 0 0
Duration of responses according to iRECIST and RECIST 1.1
Timepoint [5] 0 0
up to 24 month
Secondary outcome [6] 0 0
Response rate according to RECIST 1.1
Timepoint [6] 0 0
up to 24 month
Secondary outcome [7] 0 0
Disease control rate according to iRECIST and RECIST 1.1
Timepoint [7] 0 0
up to 24 month
Secondary outcome [8] 0 0
Progression free survival (PFS)
Timepoint [8] 0 0
up to 42 month
Secondary outcome [9] 0 0
Overall survival (OS)
Timepoint [9] 0 0
up to 42 month
Secondary outcome [10] 0 0
Occurrence of eftilagimod alpha-specific antibodies (ADA)
Timepoint [10] 0 0
up to 24 month
Secondary outcome [11] 0 0
Plasma concentration time profile of eftilagimod alpha
Timepoint [11] 0 0
up to 24 month

Eligibility
Key inclusion criteria
Main

1. Part A (1st line, PD-X naïve NSCLC): histologically- or cytologically-confirmed
diagnosis of non-small cell lung carcinoma stage IIIB not amenable to curative
treatment or stage IV not amenable to EGFR/ALK based therapy, treatment naïve for
systemic therapy given for advanced/metastatic disease (previous palliative
radiotherapy for advanced/metastatic disease acceptable)

Part B (2nd line, PD-X refractory NSCLC): histologically- or cytologically-confirmed
diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with
at least 2 cycles of any PD-1/PD-L1 containing based therapy (e.g. nivolumab,
pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other
immunotherapeutic or chemotherapy given as part of first-line treatment.

Part C (2nd line PD-X naive HNSCC): Histologically- or cytologically-confirmed
recurrent disease not amenable to curative treatment with local or systemic therapy,
or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and
larynx that is considered incurable by local therapies after failure of prior
platinum-based therapy.

2. Submission of formalin-fixed diagnostic tumor tissue

3. ECOG performance status 0-1.

4. Expected survival > 3 months.

Main
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. For part A (1st line, PD-X naïve NSCLC):

- The NSCLC can be treated with curative intent with either surgical resection
and/or chemoradiation and/or radiation.

- Has received systemic therapy for the treatment of their stage IV NSCLC.
Completion of treatment with chemotherapy and/or radiation as part of
neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least
6 months prior to the diagnosis of metastatic disease.

- EGFR-sensitizing mutation and/or is EML4 gene/ ALK gene fusion positive (ALK
translocation).

For Part B (2nd line, PD-X refractory NSCLC):

- Symptomatic ascites or pleural effusion.

- > 1 line of chemotherapy for metastatic disease.

For Part C (2nd line PD-X naive HNSCC):

- Disease is suitable for local therapy administered with curative intent.

- Previously treated with > 1 systemic regimens for recurrent and/or metastatic
disease.

2. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
(Part A and C only)

3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent 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 that treatment due to a Grade 3 or
higher irAE (Part B only)

4. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery,
another systemic cancer therapy or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to cycle 1 day 1.

Note: Patients must have recovered from all AEs due to previous therapies to =Grade 1
or baseline. Patients with =Grade 2 neuropathy, alopecia and elevated transaminases in
case of liver metastases may be eligible. If patient received major surgery, they must
have recovered adequately from the toxicity and/or complications from the intervention
prior to starting study treatment. Participants who have entered the follow-up phase
of an investigational study may participate as long as it has been 4 weeks after the
last dose of the previous investigational agent.

5. Known active central nervous system metastasis and/or carcinomatous meningitis.
Patients with previously treated brain metastases may participate provided they are
radiologically stable: i.e. without evidence of progression for at least 4 weeks by
repeat imaging, clinically stable and without requirement for steroid treatment for at
least 14 days prior to cycle 1 day 1.

6. Receives continuous systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalents) or other immunosuppressive medications within 7 days prior to
cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up
to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Tasman Health Care - Southport
Recruitment hospital [2] 0 0
St John of God Subiaco Hospital - Perth
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
WA 6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Madrid
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Glasgow
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Immutep S.A.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab
in non-small cell lung carcinoma and head and neck carcinoma patients.
Trial website
https://clinicaltrials.gov/show/NCT03625323
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
Frederic Triebel
Address 0 0
Country 0 0
Phone 0 0
+33660916539
Fax 0 0
Email 0 0
frederic.triebel@immutep.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03625323