Non-Small Cell Lung CancerPhase 2NCT02673814
Phase 2 Trial of Durvalumab With or Without Bavituximab in Patients With Previously Treated Metastatic Non-small-cell Lung Cancer
A Phase 2 study testing durvalumab and bavituximab in people with Non-Small Cell Lung Cancer, run by Peregrine Pharmaceuticals.
Trial summary
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to durvalumab will improve the results of the treatment for non-small-cell lung cancer. 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?
- durvalumab and bavituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2018
- 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 Written Informed Consent
- Male or female at least 18 years of age
- Histologically or cytologically documented NSCLC (Non-small-cell lung carcinoma) who present with Stage IV disease (according to the American Joint Committee on Cancer Staging Manual [7th edition]) or with recurrent disease or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease)
- Disease recurrence or progression during or after one prior platinum-based doublet chemotherapy treatment for advanced or metastatic disease
- Measurable disease on cross-sectional imaging per RECIST 1.1
- Eastern Cooperative Oncology Group performance status 0 or 1
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- Tumor tissue (archival or recent tumor biopsy) must be available for biomarker evaluation
- Adequate hematologic function (absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL).
- Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
- Adequate hepatic function (serum bilirubin ≤1.5 × ULN, serum albumin levels ≥3.0 g/dL, alanine aminotransferase [ALT] ≤2.5 × ULN, and aspartate aminotransferase [AST] ≤2.5 × ULN)
- Female patients must either be of nonreproductive potential or must have a negative serum pregnancy test upon study entry
- All patients of reproductive potential (ie, not surgically sterile or postmenopausal) must agree to use a highly effective method of contraception during and 90 days after the end of study treatment
Who cannot join
- Known history of bleeding diathesis or coagulopathy (von Willebrand disease or hemophilia)
- Tumors invading large blood vessels that, in the opinion of the Investigator, put the patient at risk for major hemorrhage
- Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer)
- Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening
- Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months prior to screening
- QT interval using Fridericia's Correction (QTc) > 500 ms
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- Symptomatic or clinically active brain metastases. Patients are eligible if brain metastases are adequately treated. Patients must be either off corticosteroids or on a stable or decreasing dose of ≤10 mg of daily prednisone (or equivalent).
- Patients with symptomatic interstitial lung disease or inflammatory pneumonitis that may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Other active malignancy requiring concurrent intervention.
- Acute toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 or baseline before administration of study drug
- Active or prior documented autoimmune disease within the past 2 years
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency
- History of allogeneic organ transplant
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
- Previous clinical diagnosis of tuberculosis
- History of hypersensitivity to any of the excipients of bavituximab and durvalumab including polysorbate-80-containing infusions.
- Serious nonhealing wound, including wound healing by secondary intention
- Major surgery within 4 weeks prior to Cycle 1 Day 1 (C1D1)
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
- Prior therapy with a PD-1 or PD-L1 inhibitor, including durvalumab.
- Prior therapy with bavituximab.
- Investigational therapy within 28 days prior to C1D1.
- Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
About this study
Official title: An Open-Label, Randomized, Phase II Trial of Durvalumab (MEDI4736) With or Without Bavituximab in Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to durvalumab will improve the results of the treatment for non-small-cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- durvalumab, bavituximab
- 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.
durvalumabBiological
Also called MEDI4736
bavituximabBiological
| Study group | Role | What they receive |
|---|---|---|
| Arm A (durvalumab) | Experimental | 10 mg/kg durvalumab alone every two weeks Receives: Biological: durvalumab |
| Arm B (bavituximab + durvalumab) | Experimental | 3 mg/kg bavituximab weekly in combination with 10 mg/kg durvalumab every two weeks Receives: Biological: durvalumab; Biological: bavituximab |
| Arm C (bavituximab + durvalumab) | Experimental | 3 mg/kg bavituximab in combination with 10 mg/kg durvalumab both every two weeks Receives: Biological: durvalumab; Biological: bavituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (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 CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673814
- Sponsor's protocol ID
- PPHM 1501
- Status last verified
- Jul 2016
- First submitted
- 2 Feb 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Phase II Trial of Durvalumab (MEDI4736) With or Without Bavituximab in Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02673814
- Acronym / sponsor ID
- PPHM 1501
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 4 Feb 2016 (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 research study is to see whether adding bavituximab (an investigational drug) to durvalumab will improve the results of the treatment for non-small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (durvalumab) | Experimental | Biological: durvalumab10 mg/kg durvalumab alone every two weeks |
| Arm B (bavituximab + durvalumab) | Experimental | Biological: durvalumab, Biological: bavituximab3 mg/kg bavituximab weekly in combination with 10 mg/kg durvalumab every two weeks |
| Arm C (bavituximab + durvalumab) | Experimental | Biological: durvalumab, Biological: bavituximab3 mg/kg bavituximab in combination with 10 mg/kg durvalumab both every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed Written Informed Consent
- Male or female at least 18 years of age
- Histologically or cytologically documented NSCLC (Non-small-cell lung carcinoma) who present with Stage IV disease (according to the American Joint Committee on Cancer Staging Manual [7th edition]) or with recurrent disease or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease)
- Disease recurrence or progression during or after one prior platinum-based doublet chemotherapy treatment for advanced or metastatic disease
- Measurable disease on cross-sectional imaging per RECIST 1.1
Key exclusion criteria (25 listed)
- Known history of bleeding diathesis or coagulopathy (von Willebrand disease or hemophilia)
- Tumors invading large blood vessels that, in the opinion of the Investigator, put the patient at risk for major hemorrhage
- Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer)
- Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening
- Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months prior to screening
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 |
|---|---|---|
| durvalumabAlso: MEDI4736 | Biological | Arm A (durvalumab), Arm B (bavituximab + durvalumab), Arm C (bavituximab + durvalumab) |
| bavituximab | Biological | Arm B (bavituximab + durvalumab), Arm C (bavituximab + durvalumab) |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24 months
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 1 Aug 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing durvalumab and bavituximab in people with Non-Small Cell Lung Cancer, run by Peregrine Pharmaceuticals.
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 12 inclusion and 25 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 (ORR) (time frame: 24 months). 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 1 Aug 2016.