Non-small Cell Lung Cancer (NSCLC)Phase 1/2NivokinNCT05468294
F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer
A Phase 1/2 study testing F16IL2 and Nivolumab, fixed dose in people with Non-small Cell Lung Cancer (NSCLC), run by Philogen S.p.A. at 1 site in Switzerland.
Trial summary
Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- F16IL2 and Nivolumab, fixed dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Mar 2017to Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years.
- Subjects with histologically or cytologically-documented locally advanced NSCLC who present with stage IVA or IVB according to the 8th TNM classification. Pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology.
- Previous treatment/s for NSCLC with platinum-based 1st line therapy regimen with or without maintainance therapy and documented disease progression. First line platinum-based therapy has to consist of at least 4 cycles.
- Patients with a known sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with afatinib, erlotinib, gefitinib, or another EGFR-TKI approved for the treatment of EGFR-mutant NSCLC. Patients with a known ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with crizotinib or another ALK-TKI approved for the treatment of NSCLC in patients having an ALK fusion oncogene.
- Evaluable tumor tissue available (either FFPE tissue block or unstained tumor tissue section); fresh or archival.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
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- Patients must have at least one unidimensionally measurable lesion by computed tomography or MRIas defined by RECIST criteria 1.1.
- Prior radiation therapy is allowed, if the irradiated area is not the only source of measurable or assessable disease and if the radiation therapy is not within 4 weeks of the administration of study treatment.
- All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1.
- All baseline laboratory requirements will be assessed and should be obtained within 21 days of treatment start. Screening laboratory values must meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, platelets ≥ 100 x 109/L, haemoglobin (Hb) ≥ 9.0 g/dl.
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) ≤ 3 x upper limit of reference range (ULN), and total bilirubin ≤ 2.0 mg/L unless liver involvement by the tumor, in which case the transaminase levels could be ≤ 5 x ULN.
- Creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min.
- Estimated life expectancy of at least 12 weeks.
- Negative serum pregnancy test for females of childbearing potential*.
- Documented negative test for HIV, HBV and HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBsAb with no history of vaccination and/or anti-HBcAb), negative serum HBV-DNA is required. For HCV: HCV RNA or HCV antibody test. Subjects with a positive tst for HCV antibody but no detection of HCV RNA indicating no current infection are eligible.
- Negative TB test (e.g. Mantoux or Quantiferon assay)
- Written informed consent.
- Subjects or legal rappresentative must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
- Women of childbearing potential (WOCBP) must be using, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesteron-only or combined (estrogen- and progesteron-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomised partner. Pregnancy test will be repeated at the end of treatment visit.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilised (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Who cannot join
- Cancer-specific exclusions
- Any tumor therapy (chemotherapy, biologics for cancer, or an investigational therapy) within 4 weeks of the administration of study treatment.
- Uncontrolled tumor-related pain; patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment.
- Active symptomatic central nervous system metastases. Subjects are eligible if CNS metastases have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to the first administration of study treatment.
- Subjects must have been either off corticosteroids, or on a stable or decreasing dose ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to enrollment.
- Carcinomatous meningitis
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- General Medical Exclusions
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study or any cancer curatively treated < 5 years prior to study entry, except cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumors.
- Pregnant and lactating women.
- Uncontrolled medical condition considered as high risk for the treatment with an investigational drug (e.g. unstable diabetes mellitus, vena-cava-syndrome, uncontrolled pleural effusion, pericardial effusion).
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Heart failure (> Grade II, New York Heart Association Criteria - NYHA).
- History within the last 12 months of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Irreversible cardiac arrhythmias requiring permanent medication.
- History of stroke or transient ischemic attack within the previous 12 months.
- Severe or uncontrolled hypertension according to WHO criteria.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Documented history or active autoimmune disorders with the exception of:
- skin disorders (such as vitiligo, psoriasis, or alopecia),
- stable diabetes mellitus type 1,
- Autoimmune thyroiditis requiring hormone replacement only.
- Presence of primary or secondary immune deficiency.
- Major trauma including surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Known history of allergy to IL-2 or other intravenously administered human proteins/peptides/antibodies.
- Neuropathy > Grade 2.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- Exclusion criteria related to medication
- Treatment with any investigational study drug within 4 weeks before beginning of study treatment.
- Treatment with hematopoietic growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
- Immunosuppressive treatment within 2 weeks prior to cycle 1, day 1.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to start of study drug (inhaled steroids and adrenal replacement steroid doses are permitted in absence of any active autoimmune disease)
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Treatment with systemic immunostimulatory agents (including but not limited to IFNs and IL-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/IIb Study of the Tumor Targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-PD1 Antibody Nivolumab in Patients With Non-small Cell Lung Cancer
Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.
Read the detailed description
The study will take place in two phases. In Phase I, the MTD and RD will be defined following a traditional 3+3 design and patients will be treated in cohorts of 3 to 6 patients with a fixed dose of Nivolumab (3 mg/kg) and escalating doses of F16IL2.
Following successful completion of the dose-finding, the study will proceed to Phase IIb and 17 patients will be treated with Nivolumab (3 mg/kg) and F16IL2 at the RD determined in Phase I.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- F16IL2, Nivolumab, fixed dose
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F16IL2Drug
F16IL2 infusion will be always administered in 180 minutes i.v. on day 1, 8, 15 and 22 of each 28-days cycle.
Nivolumab, fixed doseDrug
Patients will receive 3 mg/kg of Nivolumab as a 60 minutes i.v. infusion on day 1 and day 15 of each 28-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ph I: F16IL2 + Nivolumab | Experimental | Patients will receive a fixed dose of Nivolumab and the following increasing dose levels of F16IL2: 15, 30, 50 and 70 Mio IU.
Once the RD is established, 17 patients will receive a fixed dose of Nivolumab and F16IL2 at the RD, established during the Phase I part of the study. Receives: Drug: F16IL2; Drug: Nivolumab, fixed dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I study
Measured: From Day 1 to Day 28 of treatment cycle
Objective response rate (ORR) - phase II study
Measured: At week 8
Objective response rate (ORR) - phase II study
Measured: At week 16
Objective response rate (ORR) - phase II study
Measured: At week 24
Secondary outcomes (9)
Human anti-fusion protein antibodies (HAFA) levels - phase I study
Measured: 1) at day 1; 2) at day 29; 3) at day 57; 4) at day 85; 5) at day 127; 6) at day 169;
Objective response rate (ORR) - phase I study
During treatment and after completion of administration of both Nivolumab and F16IL2 every 8 weeks up to 6 months after study initiation and then every 12 weeks until 12 months after study initiation
Measured: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Progression-free survival (PFS) - phase I study
Time from treatment start to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause
Measured: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Median overall survival (mOS) - phase I study
Measured: From day 1 up to 1 year
Percentage of Participants With On-Study Adverse Events (AEs) and Serious Adverse Events (SAEs) - phase II study
Measured: From day 1 up to 1 year
Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities - phase II study
Measured: 1) From treatment initiation to day 112 (week 16), every week; 2) At day 168 (week 24) from treatment initiation, every 12 weeks, up to 12 months
Progression-free survival (PFS) - phase II study
Time from treatment start to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause
Measured: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Median overall survival (mOS) - phase II study
Measured: From day 1 up to 1 year
Human anti-fusion protein antibodies (HAFA) levels - phase II study
Measured: 1) at day 1; 2) at day 29; 3) at day 57; 4) at day 85; 5) at day 127; 6) at day 169;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start9 Mar 2017
- Primary completion31 Dec 2021
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468294
- Sponsor's protocol ID
- PH-F16IL2PD1-01/16
- Acronym
- Nivokin
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIb Study of the Tumor Targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-PD1 Antibody Nivolumab in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05468294
- Acronym / sponsor ID
- Nivokin / PH-F16IL2PD1-01/16
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Jul 2022 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.
Detailed description
The study will take place in two phases. In Phase I, the MTD and RD will be defined following a traditional 3+3 design and patients will be treated in cohorts of 3 to 6 patients with a fixed dose of Nivolumab (3 mg/kg) and escalating doses of F16IL2.
Following successful completion of the dose-finding, the study will proceed to Phase IIb and 17 patients will be treated with Nivolumab (3 mg/kg) and F16IL2 at the RD determined in Phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ph I: F16IL2 + Nivolumab | Experimental | Drug: F16IL2, Drug: Nivolumab, fixed dosePatients will receive a fixed dose of Nivolumab and the following increasing dose levels of F16IL2: 15, 30, 50 and 70 Mio IU. Once the RD is established, 17 patients will receive a fixed dose of Nivolumab and F16IL2 at the RD, established during the Phase I part of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients aged 18-75 years.
- Subjects with histologically or cytologically-documented locally advanced NSCLC who present with stage IVA or IVB according to the 8th TNM classification. Pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology.
- Previous treatment/s for NSCLC with platinum-based 1st line therapy regimen with or without maintainance therapy and documented disease progression. First line platinum-based therapy has to consist of at least 4 cycles.
- Patients with a known sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with afatinib, erlotinib, gefitinib, or another EGFR-TKI approved for the treatment of EGFR-mutant NSCLC. Patients with a known ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with crizotinib or another ALK-TKI approved for the treatment of NSCLC in patients having an ALK fusion oncogene.
- Evaluable tumor tissue available (either FFPE tissue block or unstained tumor tissue section); fresh or archival.
Key exclusion criteria (36 listed)
- Cancer-specific exclusions
- Any tumor therapy (chemotherapy, biologics for cancer, or an investigational therapy) within 4 weeks of the administration of study treatment.
- Uncontrolled tumor-related pain; patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment.
- Active symptomatic central nervous system metastases. Subjects are eligible if CNS metastases have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to the first administration of study treatment.
- Subjects must have been either off corticosteroids, or on a stable or decreasing dose ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F16IL2F16IL2 infusion will be always administered in 180 minutes i.v. on day 1, 8, 15 and 22 of each 28-days cycle. | Drug | Ph I: F16IL2 + Nivolumab |
| Nivolumab, fixed dosePatients will receive 3 mg/kg of Nivolumab as a 60 minutes i.v. infusion on day 1 and day 15 of each 28-days cycle. | Drug | Ph I: F16IL2 + Nivolumab |
Primary outcome
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I study
Time frame: From Day 1 to Day 28 of treatment cycle
Objective response rate (ORR) - phase II study
Time frame: At week 8
Objective response rate (ORR) - phase II study
Time frame: At week 16
Objective response rate (ORR) - phase II study
Time frame: At week 24
9 secondary outcomes
Human anti-fusion protein antibodies (HAFA) levels - phase I study
Time frame: 1) at day 1; 2) at day 29; 3) at day 57; 4) at day 85; 5) at day 127; 6) at day 169;
Objective response rate (ORR) - phase I study
Time frame: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Progression-free survival (PFS) - phase I study
Time frame: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Median overall survival (mOS) - phase I study
Time frame: From day 1 up to 1 year
Percentage of Participants With On-Study Adverse Events (AEs) and Serious Adverse Events (SAEs) - phase II study
Time frame: From day 1 up to 1 year
Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities - phase II study
Time frame: 1) From treatment initiation to day 112 (week 16), every week; 2) At day 168 (week 24) from treatment initiation, every 12 weeks, up to 12 months
Progression-free survival (PFS) - phase II study
Time frame: 1) At day 52 - 56 (week 8) every 8 weeks up to 12 months; 2) At day 98 - 112 (week 16) every 8 weeks up to 12 months; 3) from week 24 every 12 weeks untils 12 months
Median overall survival (mOS) - phase II study
Time frame: From day 1 up to 1 year
Human anti-fusion protein antibodies (HAFA) levels - phase II study
Time frame: 1) at day 1; 2) at day 29; 3) at day 57; 4) at day 85; 5) at day 127; 6) at day 169;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing F16IL2 and Nivolumab, fixed dose in people with Non-small Cell Lung Cancer (NSCLC), run by Philogen S.p.A. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I study (time frame: From Day 1 to Day 28 of treatment cycle). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.