Solid TumorPhase 1NCT03511222
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
A Phase 1 study testing Vorolanib, Nivolumab and Pembrolizumab in people with Solid Tumor and Hepatocellular Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hepatocellular Carcinoma, Gastric Cancer
- What is being tested?
- Vorolanib, Nivolumab and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 28 May 2020
- 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
- Dose escalation cohort: histologically or cytologically confirmed diagnosis of a solid tumor that can be treated with either pembrolizumab or nivolumab as part of standard of care or whom no standard of therapy exists except pembrolizumab or nivolumab
- SCLC cohort: histologically or cytologically confirmed diagnosis of small cell lung cancer whose disease progressed on platinum-based chemotherapy or refused chemotherapy
- Evidence of measurable disease per RECIST 1.1. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Normal bone marrow and organ function as defined below:
Show all 19Show fewer
- Leukocytes ≥ 2,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases or hepatocellular carcinoma (HCC))
- Creatinine ≤ 1.5 x IULN OR measured or calculated creatinine clearance ≥ 50 mL/min for patients with creatinine levels > 1.5 x IULN
- Urine protein ≤1+ or urine protein to creatinine ratio ≤ 1; if UPC ratio is >1 on urinalysis, then 24-hour urine collection from protein must be obtained and level must be <1,000 mg for patient enrollment.
- aPTT and either INR or PT ≤ 1.5 x ILUN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant.
- Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible. Patients with clinically evident CNS hemorrhage on scans are excluded.
- Women of childbearing 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 31 weeks after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Presence of a concurrent active, incurable malignancy that may alter the outcome of the treatment for disease under treatment as determined by the treating physician.
- Receiving any other investigational agents within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
- Prior PD-1 or PD-L1 inhibitor therapy, or prior therapy with anti-PD-L2 or anti-CTLA-4 inhibitor, or any other drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorolanib, nivolumab or pembrolizumab (as applicable), any monoclonal antibody, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g. contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergens) is permitted.
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- Toxicities from prior therapy must have resolved to G1 or less prior to the first dose of study drug except those deemed not clinically significant per PI.
- Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes but is not limited to: history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. Patients with vitiligo or endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome, and psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger (precipitating event) are eligible.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- History of clinically significant bleeding.
- Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction, and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.
- Inability to swallow or retain oral medications or the presence of active GI disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of vorolanib.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 24 hours of study entry.
- Active hepatitis B or hepatitis C. Note: no testing for hepatitis B or C is required unless mandated by local health authority.
- Has a known history of active tuberculosis.
- Known HIV-positivity.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
- Major surgery within the last 4 weeks; minor surgery within the last 2 weeks.
- Any radiotherapy within 3 weeks except palliative stereotactic body radiation therapy (SBRT) within 2 weeks.
- Prior anti-cancer therapy given within 21 days or 5 half-lives (whichever is shorter)
- Chemotherapy given on the weekly basis with limited potential for delayed toxicity within the last 2 weeks.
- Concurrent use of any medications or substances (e.g. herbal supplement or food) known to be a strong inhibitor or strong inducer of CYP3A4.
- Symptomatic arterial peripheral vascular disease or significant cardiovascular disease or condition including:
- Congestive heart failure (CHF) currently requiring therapy.
- Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Criteria.
- Need for antiarrhythmic medical therapy for a ventricular arrhythmia.
- Severe conduction disturbance (e.g. 3rd degree heart block).
- Unstable angina pectoris (i.e. last episode ≤ 6 months prior to first dose of protocol-indicated treatment).
- Uncontrolled (per investigator judgment) hypertension.
- Myocardial infarction within 6 months prior to starting trial treatment.
- QTcF >450 ms in men, or >470 ms in women.
- Deep vein thrombosis or pulmonary embolism ≤ 4 weeks before first dose of protocol-indicated treatment, unless adequately treated and stable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase IB Trial of Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.
- Conditions
- Solid Tumor, Hepatocellular Carcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Being tested
- Vorolanib, Nivolumab, Pembrolizumab
- Medical subject headings
- Carcinoma, Hepatocellular, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorolanibDrug
Also called X-82
Patients should take vorolanib at approximately the same time every day with food.
NivolumabDrug
Also called Opdivo
Standard of care
PembrolizumabDrug
Also called Keytruda
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: Vorolanib + Nivolumab | Experimental | * Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level.
* Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST Receives: Drug: Vorolanib; Drug: Nivolumab |
| Dose Escalation: Vorolanib + Pembrolizumab | Experimental | * Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level
* Patients receiving pembrolizumab will get it on an outpatient basis as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 200 mg on Day 1 of each 21-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST Receives: Drug: Vorolanib; Drug: Pembrolizumab |
| Vorolanib + Nivolumab (Small Cell Lung Cancer) | Experimental | * Vorolanib is an oral drug which will be administered daily on an outpatient basis at 300 mg daily
* Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST Receives: Drug: Vorolanib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose (RP2D) of vorolanib plus pembrolizumab
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.
Measured: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)
Recommended phase II dose (RP2D) of vorolanib plus nivolumab
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.
Measured: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)
Secondary outcomes (2)
Safety and toxicity of vorolanib plus pembrolizumab as measured by the number and type of adverse events experienced by participant
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Measured: 30 days after completion of treatment (estimated to be 7 months)
Safety and toxicity of vorolanib plus nivolumab as measured by the number and type of adverse events experienced by participant
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Measured: 30 days after completion of treatment (estimated to be 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start11 Sep 2018
- Primary completion15 Aug 2019
- Study completion28 May 2020
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xcovery Holdings, Inc.
- Responsible party
- Sponsor
- Investigators
- Nusayba A Bagegni, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511222
- Sponsor's protocol ID
- 201806087
- Status last verified
- Jul 2020
- First submitted
- 18 Apr 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagegni NA, Park H, Kraft K, O-Toole M, Gao F, Waqar SN, Ratner L, Morgensztern D, Devarakonda S, Amin M, Baggstrom MQ, Liang C, Selvaggi G, Wang-Gillam A. Phase 1b trial of anti-VEGF/PDGFR vorolanib combined with immune checkpoint inhibitors in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2022 Apr;89(4):487-497. doi: 10.1007/s00280-022-04406-6. Epub 2022 Mar 5.
PubMed 35247086
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Trial of Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03511222
- Acronym / sponsor ID
- 201806087
- Conditions
- Solid Tumor, Hepatocellular Carcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Xcovery Holdings, Inc.
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 27 Apr 2018 (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.
The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Vorolanib + Nivolumab | Experimental | Drug: Vorolanib, Drug: Nivolumab* Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level. * Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST |
| Dose Escalation: Vorolanib + Pembrolizumab | Experimental | Drug: Vorolanib, Drug: Pembrolizumab* Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level * Patients receiving pembrolizumab will get it on an outpatient basis as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 200 mg on Day 1 of each 21-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST |
| Vorolanib + Nivolumab (Small Cell Lung Cancer) | Experimental | Drug: Vorolanib, Drug: Nivolumab* Vorolanib is an oral drug which will be administered daily on an outpatient basis at 300 mg daily * Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Dose escalation cohort: histologically or cytologically confirmed diagnosis of a solid tumor that can be treated with either pembrolizumab or nivolumab as part of standard of care or whom no standard of therapy exists except pembrolizumab or nivolumab
- SCLC cohort: histologically or cytologically confirmed diagnosis of small cell lung cancer whose disease progressed on platinum-based chemotherapy or refused chemotherapy
- Evidence of measurable disease per RECIST 1.1. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
- At least 18 years of age.
- ECOG performance status ≤ 1
Key exclusion criteria (32 listed)
- Presence of a concurrent active, incurable malignancy that may alter the outcome of the treatment for disease under treatment as determined by the treating physician.
- Receiving any other investigational agents within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
- Prior PD-1 or PD-L1 inhibitor therapy, or prior therapy with anti-PD-L2 or anti-CTLA-4 inhibitor, or any other drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorolanib, nivolumab or pembrolizumab (as applicable), any monoclonal antibody, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
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 |
|---|---|---|
| VorolanibAlso: X-82Patients should take vorolanib at approximately the same time every day with food. | Drug | Dose Escalation: Vorolanib + Nivolumab, Dose Escalation: Vorolanib + Pembrolizumab, Vorolanib + Nivolumab (Small Cell Lung Cancer) |
| NivolumabAlso: OpdivoStandard of care | Drug | Dose Escalation: Vorolanib + Nivolumab, Vorolanib + Nivolumab (Small Cell Lung Cancer) |
| PembrolizumabAlso: KeytrudaStandard of care | Drug | Dose Escalation: Vorolanib + Pembrolizumab |
Primary outcome
Recommended phase II dose (RP2D) of vorolanib plus pembrolizumab
Time frame: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.
Recommended phase II dose (RP2D) of vorolanib plus nivolumab
Time frame: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.
2 secondary outcomes
Safety and toxicity of vorolanib plus pembrolizumab as measured by the number and type of adverse events experienced by participant
Time frame: 30 days after completion of treatment (estimated to be 7 months)
Safety and toxicity of vorolanib plus nivolumab as measured by the number and type of adverse events experienced by participant
Time frame: 30 days after completion of treatment (estimated to be 7 months)
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 35247086Bagegni NA, Park H, Kraft K, O-Toole M, Gao F, Waqar SN, Ratner L, Morgensztern D, Devarakonda S, Amin M, Baggstrom MQ, Liang C, Selvaggi G, Wang-Gillam A. Phase 1b trial of anti-VEGF/PDGFR vorolanib combined with immune checkpoint inhibitors in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2022 Apr;89(4):487-497. doi: 10.1007/s00280-022-04406-6. Epub 2022 Mar 5.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Nusayba A Bagegni, M.D. principal investigator
Washington University School of Medicine
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 Vorolanib, Nivolumab and Pembrolizumab in people with Solid Tumor and Hepatocellular Carcinoma, run by Washington University School of Medicine 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 19 inclusion and 32 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 Jul 2020. 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: Low accrual). 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?
Recommended phase II dose (RP2D) of vorolanib plus pembrolizumab (time frame: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511222, which also lists 1 linked publication.
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 Jul 2020.