MelanomaPhase 1NCT01984255
A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
A Phase 1 study testing Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV and Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. in people with Melanoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a Open label, two-arm, randomized, two agent, single center trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV and Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 1
- 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
- Histologic diagnosis of unresectable or metastatic melanoma. For unknown primary disease, diagnosis of metastatic disease by cytology FNA (Fine Needle Aspiration) is not acceptable.
- Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab or bavituximab.
- Subjects must have measurable disease as defined by irRC. All sites must be evaluated within 4 weeks prior to beginning therapy.
- Age ≥ 18 years.
- Performance status ECOG (Eastern Cooperative Oncology Group) 0-2.
- Adequate organ and marrow function as defined below:
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- leukocytes ≥ 2,000/mcL (Microliter)
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcl
- total bilirubin < 3X (times) institutional upper limit of normal
- AST (Aspartate Aminotransferase) (SGOT)/ALT (Alanine Aminotransferase)(SPGT) ≤ 2.5 X institutional upper limit of normal
- creatinine < 3X institutional upper limit of normal
- hemoglobin >8g/dL
- Ability to understand and the willingness to sign a written informed consent.
- Subjects must be willing to undergo tumor biopsy pretreatment and at weeks 3 and 15.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- No concomitant therapy with any of the following: IL2 (Interleukin 2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; all such therapies must have been discontinued >4weeks.
- No infection with HIV and no active infection with hepatitis B and no active or chronic infection with hepatitis C. Due to the mechanism of action of ipilimumab, activity and side effects in an immune compromised patient are unknown.
- Subjects with active CNS (Central nervous system) disease are excluded. Patient with brain metastases previously treated with surgery or stereotactic radiosurgery and with confirmed SD for >8 weeks are allowed.
- Subjects are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing.
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- Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topic steroids is permitted).
- Subjects are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks (28 days) prior to or after any dose of ipilimumab.
- Subjects are excluded if they have a history of prior treatment with ipilimumab, CD137 agonist , CTLA-4 inhibitor (Cytotoxic T-Lymphocyte Antigen 4) or agonist or bavituximab.
- Patients are excluded if they have a history of autoimmune disease except controlled and stable autoimmune thyroiditis. The excluded autoimmune diseases include acute disseminated encephalomyelitis, Addison's disease, alopecia universalis, ankylosing spondylitis, antiphospholipid antibody syndrome, aplastic anemia, asthma, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune hypoparathyroidism, autoimmune hypophysitis, autoimmune myocarditis, autoimmune oophoritis, autoimmune orchitis, autoimmune thrombocytopenic purpura, Behcet's disease, bullous pemphigoid, celiac disease, chronic fatigue syndrome, chronic inflammatory demyelinating polyneuropathy, Churg-Strauss syndrome, Crohn's disease, dermatomyositis, dysautonomia, eczema, epidermolysis bullossa acquisita, gestational pemphigoid, giant cell arteritis, Goodpasture's syndrome, Graves' disease, Guillain-Barre syndrome, Hashimoto's disease-except as noted above, IgA nephropathy (Berger's disease), inflammatory bowel disease, interstitial cystitis, Kawasaki's disease, Lambert-Eaton myasthenia syndrome, lupus erythematosis, chronic Lyme disease, Meniere's syndrome, Mooren's ulcer, Morphea, multiple sclerosis, myasthenia gravis, neuromyotonia, opsoclonus myoclonus syndrome, optic neuritis, Ord's thyroiditis, pemphigus, pernicious anemia, polyarteritis nodosa, polyarthritis, polyglandular autoimmune syndrome, primary biliary cirrhosis, psoriasis, Reiter's syndrome, rheumatoid arthritis, sarcoidosis, Sjogren's syndrome, Stiff-Person syndrome, Takayasu's arteritis, ulcerative colitis, Vogt- Kovanagi-Harada disease, vulvodynia, and Wegener's granulomatosis.
- Subjects are excluded with history of thromboembolic events, clinically significant bleeding-gross hematuria, hemoptysis, or gastrointestinal bleeding, history of bleeding diathesis or hypercoagulable state, ongoing therapy with anticoagulants or non-steroidal anti-inflammatory drugs, or prior exposure to chimeric antibodies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9179
About this study
Official title: A Two-Arm, Single Center Pase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
This is a Open label, two-arm, randomized, two agent, single center trial.
Read the detailed description
This is a Open label, two-arm, randomized, two agent, single center trial.
Study Product(s), Dose, Route, Regimen:
Bavituximab 3mg/kg IVqwk (IV every week) x 14 plus ipilimumab 3mg/kg IVq3wk (IV every 3 weeks) x 4 or ipilimumab 3mg/kg IVq3wk x 4
Administration Schedule:
Patients will be randomized to one of the following arms:
Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 2 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16.
Arm B-Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8.
Randomization:
There will be a 2:1 randomization of patients to have a 3 week lead-in treatment with bavituximab followed by combination therapy of ipilimumab + bavituximab versus ipilimumab alone. The assigned treatment will be given once subject is registered successfully.
Endpoints:
Toxicities will be assessed via NCI's CTCAE (Common Terminology Criteria for Adverse Events) v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.
DCR will be measured by irRC (Immune-related Complete Response) at weeks 15, 21, 27 using the published algorithm. Disease control rate (DCR) includes complete response (CR), Partial response (PR) and stable disease (SD). Months of survival (MOS) is measured from date of entry into protocol.
Tumor MDSC (Myeloid-Derived Suppressor Cells), TAM and Treg content will be measured by IHC (ImmunoHistoChemistry). Circulating MDSC, TAM and Treg content will be measured by flow cytometry.
Peripheral blood cytokines will be measured by EIA (EIA test is a series of blood tests for diagnosing HIV infection).
- Conditions
- Melanoma
- Being tested
- Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV, Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IVDrug
Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16.
Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.Drug
Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8.
| Study group | Role | What they receive |
|---|---|---|
| A- Bavituximab plus Ipilimumab | Active comparator | Arm A-Interventions Drug: Bavituximab Dose:3mg/kg IV over 90 minutes weekly x 2 followed by Bavituximab 3mg/kg IV over 90 minutes weekly Duration-x 12 weeks plus Drug :Ipilimumab 3mg/kg IV over 90 minutes every 3 weeks Duration-x 4.weeks Receives: Drug: Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV |
| Arm B Ipilimumab | Experimental | Arm B-Interventions Drug- I3mg/kg IV over 90 minutes day 1 followed three weeks later by Drug: Ipilimumab every 3 weeks x 3weeks. Total number of treated patients will be 8. Receives: Drug: Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Toxicities will be assessed via NCI's CTCAE v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.
Measured: 12 weeks
Secondary outcomes (1)
Disease control rate (DCR)
DCR will be measured by irRC at weeks 15, 21, 27 using the published algorithm. Disease control rate (DCR) includes complete response (CR), Partial response (PR) and stable disease (SD). Months of survival (MOS) is measured from date of entry into protocol.
Measured: Months of Survival (measured at weeks 15, 21, and 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: standard of care improved combination treatment of ipilimumab plus nivolumab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Frankel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984255
- Sponsor's protocol ID
- STU 102013-007
- Other IDs
- SCCC-05613
- Status last verified
- Dec 2016
- First submitted
- 29 Oct 2013
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm, Single Center Pase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
- ClinicalTrials.gov ID
- NCT01984255
- Acronym / sponsor ID
- STU 102013-007
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: standard of care improved combination treatment of ipilimumab plus nivolumab.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Nov 2013 (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.
This is a Open label, two-arm, randomized, two agent, single center trial.
Detailed description
This is a Open label, two-arm, randomized, two agent, single center trial.
Study Product(s), Dose, Route, Regimen:
Bavituximab 3mg/kg IVqwk (IV every week) x 14 plus ipilimumab 3mg/kg IVq3wk (IV every 3 weeks) x 4 or ipilimumab 3mg/kg IVq3wk x 4
Administration Schedule:
Patients will be randomized to one of the following arms:
Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 2 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16.
Arm B-Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8.
Randomization:
There will be a 2:1 randomization of patients to have a 3 week lead-in treatment with bavituximab followed by combination therapy of ipilimumab + bavituximab versus ipilimumab alone. The assigned treatment will be given once subject is registered successfully.
Endpoints:
Toxicities will be assessed via NCI's CTCAE (Common Terminology Criteria for Adverse Events) v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.
DCR will be measured by irRC (Immune-related Complete Response) at weeks 15, 21, 27 using the published algorithm. Disease control rate (DCR) includes complete response (CR), Partial response (PR) and stable disease (SD). Months of survival (MOS) is measured from date of entry into protocol.
Tumor MDSC (Myeloid-Derived Suppressor Cells), TAM and Treg content will be measured by IHC (ImmunoHistoChemistry). Circulating MDSC, TAM and Treg content will be measured by flow cytometry.
Peripheral blood cytokines will be measured by EIA (EIA test is a series of blood tests for diagnosing HIV infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A- Bavituximab plus Ipilimumab | Active comparator | Drug: Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IVArm A-Interventions Drug: Bavituximab Dose:3mg/kg IV over 90 minutes weekly x 2 followed by Bavituximab 3mg/kg IV over 90 minutes weekly Duration-x 12 weeks plus Drug :Ipilimumab 3mg/kg IV over 90 minutes every 3 weeks Duration-x 4.weeks |
| Arm B Ipilimumab | Experimental | Drug: Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.Arm B-Interventions Drug- I3mg/kg IV over 90 minutes day 1 followed three weeks later by Drug: Ipilimumab every 3 weeks x 3weeks. Total number of treated patients will be 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologic diagnosis of unresectable or metastatic melanoma. For unknown primary disease, diagnosis of metastatic disease by cytology FNA (Fine Needle Aspiration) is not acceptable.
- Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab or bavituximab.
- Subjects must have measurable disease as defined by irRC. All sites must be evaluated within 4 weeks prior to beginning therapy.
- Age ≥ 18 years.
- Performance status ECOG (Eastern Cooperative Oncology Group) 0-2.
Key exclusion criteria (11 listed)
- No concomitant therapy with any of the following: IL2 (Interleukin 2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; all such therapies must have been discontinued >4weeks.
- No infection with HIV and no active infection with hepatitis B and no active or chronic infection with hepatitis C. Due to the mechanism of action of ipilimumab, activity and side effects in an immune compromised patient are unknown.
- Subjects with active CNS (Central nervous system) disease are excluded. Patient with brain metastases previously treated with surgery or stereotactic radiosurgery and with confirmed SD for >8 weeks are allowed.
- Subjects are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IVBavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16. | Drug | A- Bavituximab plus Ipilimumab |
| Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8. | Drug | Arm B Ipilimumab |
Primary outcome
Toxicities
Time frame: 12 weeks
Toxicities will be assessed via NCI's CTCAE v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.
1 secondary outcome
Disease control rate (DCR)
Time frame: Months of Survival (measured at weeks 15, 21, and 27)
Results and safety
The study was stopped early (reason given: standard of care improved combination treatment of ipilimumab plus nivolumab.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Arthur Frankel, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV and Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. in people with Melanoma, run by University of Texas Southwestern Medical Center 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 16 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Dec 2016. 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 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.
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 stopped early (reason given: standard of care improved combination treatment of ipilimumab plus nivolumab.). 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?
Toxicities (time frame: 12 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 29 Dec 2016.