Non-Small Cell Lung CancerPhase 2NCT02495636
Phase 2 Study of MPDL3280A Combined With CDX-1401 in NY-ESO 1 (+) IIIB, IV or Recurrent Non-Small Cell Lung Cancer
A Phase 2 study testing CDX-1401 and MPDL3280A in people with Non-Small Cell Lung Cancer, run by Yale University at 1 site in United States.
Trial summary
The primary purpose of this study is to look at effects, good or bad, of combining two investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in combination with a third agent, poly-ICLC, which is another investigational drug that is believed to work together with CDX-1401. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- CDX-1401 and MPDL3280A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent B. Ability to comply with the protocol C. Age ≥18 years D. Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system) E. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be counted as target lesions if clearly progressing after radiation.
- Chemotherapy naive and treated patients will be eligible, with no limit on number of prior therapies. Patients with NSCLC known to harbor an ALK rearrangement, or EGFR mutation known to be sensitive to FDA approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved EGFR TKI or ALK TKI, respectively.
- Positive NY-ESO-1 expression by RT-PCR and/or IHC will be required for entry, as determined by analysis at the trial central laboratory.
- At least one tumor amenable to excisional, core or forceps (transbronchial) biopsy. Patients must be willing to undergo tumor biopsies before starting therapy and after the 3rd CDX-1401 injection. Additionally, the first 12 patients enrolled must consent to a third tumor biopsy to be performed after the 3rd MPDL3280A infusion.
- ECOG performance status of 0 to 2 J. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 6 months after the last dose of trial therapy. Highly effective contraception is one with a failure rate of <0.1%. Birth control pills on their own do not achieve that rate.
- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
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- ANC ≥1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- Hemoglobin ≥9.0 g/dL (Patients may be transfused to meet this criterion)
- AST, ALT, and ALP ≤2.5 xULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT≤5 x ULN; Patients with documented liver or bone metastases: ALP ≤5 x ULN
- Serum bilirubin ≤1.5 xULN (Patients with known Gilbert disease who have serum bilirubin level ≤3 xULN may be enrolled)
- INR and aPTT≤1.5 x ULN (This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose)
- Serum creatinine ≤1.5 xULN or creatinine clearance ≥50 mL/min
Who cannot join
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of inhaled steroids or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic therapy (within the past 3 years) will not be excluded from the study.
- Generalized dermatologic conditions (such as allergic reactions, infection, edema, or scarring) that will not allow for study drug administration at a site of normal skin or evaluation of localized adverse events.
- Symptomatic or untreated CNS metastases. Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy. No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose are allowed. Completed stereotactic radiation at least 1 week prior to Cycle 1, Day 1 or whole-brain radiation at least 2 weeks prior to Cycle 1, Day 1 D. Treatment with systemic immunosuppressive medications (including but not limited to, prednisone at doses > 10 mg (or equivalent dose of other corticosteroids), cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [anti-TNF] agents) within 2 weeks prior to CDX-1401 administration (Inhaled or topically applied steroids, and acute and chronic standard-dose NSAIDs are permitted. Replacement steroids are also permitted).
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:
- Hormone-replacement therapy or oral contraceptives
- TKIs approved for treatment of NSCLC discontinued > 7 days prior to Cycle 1, Day 1. The baseline scan must be obtained after discontinuation of prior TKIs.
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- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment; the following exceptions are allowed:
- Unapproved/ experimental TKIs discontinued 14 days prior to Cycle 1, Day 1 G. Known infection with HIV, HBV or HCV. Patients with prior exposure to hepatitis, but no evidence of active or chronic infection, may be eligible.
- Active systemic infection requiring systemic antibiotic treatment within 72 hours prior to first dose of study treatment I. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements J. Women who are pregnant or lactating. K. Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
- Previous administration of vaccine therapy targeting NY-ESO-1 M. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to look at effects, good or bad, of combining two investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in combination with a third agent, poly-ICLC, which is another investigational drug that is believed to work together with CDX-1401. All investigational drugs, MPDL3280A and CDX-1401 in conjunction with poly-ICLC, have been evaluated separately in prior studies; however, this is the first study assessing the combination therapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- CDX-1401, MPDL3280A
- 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.
CDX-1401Drug
CDX-1401 1mg will be administered intracutaneously every 2 weeks for 4 doses (priming), followed by every 12 week dosing (booster)
MPDL3280ADrug
MPDL3280A 1200 mg will be administered intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Safety Run Up Group | Experimental | The first 12 patients to be enrolled will initiate therapy with CDX-1401 alone, with the addition of MPDL3280A the day of their 4th CDX-1401 vaccination (week 7). These patients will undergo a tumor biopsy prior to initiation of trial therapy, after their 3rd CDX-1401 vaccination (during week 6) and after their 3rd MPDL3280A infusion (during week 14 or 15, if there are no dose delays). Although we don't expect significant synergistic toxicities of combination therapy based on mechanism of action/ formulation/ administration/ distribution of CDX-1401 and past vaccine/ immune checkpoint trials, these first 12 patients will constitute a safety run in group. Receives: Drug: CDX-1401; Drug: MPDL3280A |
| Expanded Trial Group | Experimental | If there are no unexpected toxicities (no more than 3 of 12 patients with grade 3+ treatment related events as defined in 4.1.1), an additional 28 patients will be enrolled. Unlike the first 12 patients, these additional 28 patients will initiate both CDX-1401 and MPDL3280A on the same day, and will undergo tumor biopsies before starting trial therapy and after their 3rd CDX-1401 vaccination (during week 6). Receives: Drug: CDX-1401; Drug: MPDL3280A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate using RECIST v1.1
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2015 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: Study closed due to lack of enrollment
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 CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Gettinger, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495636
- Sponsor's protocol ID
- 1501015233
- Status last verified
- Jan 2017
- First submitted
- 9 Jul 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of MPDL3280A Combined With CDX-1401 in NY-ESO 1 (+) IIIB, IV or Recurrent Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02495636
- Acronym / sponsor ID
- 1501015233
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed due to lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2015 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- 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.
The primary purpose of this study is to look at effects, good or bad, of combining two investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in combination with a third agent, poly-ICLC, which is another investigational drug that is believed to work together with CDX-1401. All investigational drugs, MPDL3280A and CDX-1401 in conjunction with poly-ICLC, have been evaluated separately in prior studies; however, this is the first study assessing the combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Run Up Group | Experimental | Drug: CDX-1401, Drug: MPDL3280AThe first 12 patients to be enrolled will initiate therapy with CDX-1401 alone, with the addition of MPDL3280A the day of their 4th CDX-1401 vaccination (week 7). These patients will undergo a tumor biopsy prior to initiation of trial therapy, after their 3rd CDX-1401 vaccination (during week 6) and after their 3rd MPDL3280A infusion (during week 14 or 15, if there are no dose delays). Although we don't expect significant synergistic toxicities of combination therapy based on mechanism of action/ formulation/ administration/ distribution of CDX-1401 and past vaccine/ immune checkpoint trials, these first 12 patients will constitute a safety run in group. |
| Expanded Trial Group | Experimental | Drug: CDX-1401, Drug: MPDL3280AIf there are no unexpected toxicities (no more than 3 of 12 patients with grade 3+ treatment related events as defined in 4.1.1), an additional 28 patients will be enrolled. Unlike the first 12 patients, these additional 28 patients will initiate both CDX-1401 and MPDL3280A on the same day, and will undergo tumor biopsies before starting trial therapy and after their 3rd CDX-1401 vaccination (during week 6). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent B. Ability to comply with the protocol C. Age ≥18 years D. Histologically or cytologically documented, locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the American Joint Committee /AJCC staging system) E. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be counted as target lesions if clearly progressing after radiation.
- Chemotherapy naive and treated patients will be eligible, with no limit on number of prior therapies. Patients with NSCLC known to harbor an ALK rearrangement, or EGFR mutation known to be sensitive to FDA approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved EGFR TKI or ALK TKI, respectively.
- Positive NY-ESO-1 expression by RT-PCR and/or IHC will be required for entry, as determined by analysis at the trial central laboratory.
- At least one tumor amenable to excisional, core or forceps (transbronchial) biopsy. Patients must be willing to undergo tumor biopsies before starting therapy and after the 3rd CDX-1401 injection. Additionally, the first 12 patients enrolled must consent to a third tumor biopsy to be performed after the 3rd MPDL3280A infusion.
- ECOG performance status of 0 to 2 J. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 6 months after the last dose of trial therapy. Highly effective contraception is one with a failure rate of <0.1%. Birth control pills on their own do not achieve that rate.
Key exclusion criteria (10 listed)
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of inhaled steroids or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic therapy (within the past 3 years) will not be excluded from the study.
- Generalized dermatologic conditions (such as allergic reactions, infection, edema, or scarring) that will not allow for study drug administration at a site of normal skin or evaluation of localized adverse events.
- Symptomatic or untreated CNS metastases. Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy. No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose are allowed. Completed stereotactic radiation at least 1 week prior to Cycle 1, Day 1 or whole-brain radiation at least 2 weeks prior to Cycle 1, Day 1 D. Treatment with systemic immunosuppressive medications (including but not limited to, prednisone at doses > 10 mg (or equivalent dose of other corticosteroids), cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [anti-TNF] agents) within 2 weeks prior to CDX-1401 administration (Inhaled or topically applied steroids, and acute and chronic standard-dose NSAIDs are permitted. Replacement steroids are also permitted).
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:
- Hormone-replacement therapy or oral contraceptives
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 |
|---|---|---|
| CDX-1401CDX-1401 1mg will be administered intracutaneously every 2 weeks for 4 doses (priming), followed by every 12 week dosing (booster) | Drug | Expanded Trial Group, Safety Run Up Group |
| MPDL3280AMPDL3280A 1200 mg will be administered intravenously every 3 weeks. | Drug | Expanded Trial Group, Safety Run Up Group |
Primary outcome
Objective Response Rate
Time frame: 8 Weeks
Objective Response Rate using RECIST v1.1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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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.
Scott Gettinger, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDX-1401 and MPDL3280A in people with Non-Small Cell Lung Cancer, run by Yale University at 1 site in United States.
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 13 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Jun 2017. 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 United States. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective Response Rate (time frame: 8 Weeks). 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 22 Jun 2017.