NeoplasmsPhase 1/2INTRUSTNCT03792724
Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors
A Phase 1/2 study testing Urelumab + Nivolumab in people with Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
Open label, phase I-II study to evaluate the safety and activity of intratumoral urelumab combined with systemic nivolumab in patients with advanced solid tumors. Serial tumor and blood samples will be obtained during the study to characterize the changes induced by treatment in the tumor microenvironment, as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Urelumab + Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Jan 2019to 30 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study.
- Patients must present the following tumor types:
- For the phase I part, patients with any tumor type are eligible.
- For the phase II part, two cohorts will be established:
- Cohort A will include patients presenting tumor types with known sensitivity to Programmed cell death protein 1 (PD1)/ Programmed Death-ligand 1 (PDL1) blockade (e.g: melanoma, renal cancer, lung cancer, urothelial cancer, colorectal cancer presenting microsatellite instability (MSI), …). These patients must be naïve to PD1/PDL1 blockade.
Show all 21Show fewer
- cohort B will include patients with PD1/PDL1 sensitive tumors that have progressed following previous PD1/PDL1 blockade (e.g: melanoma, NSCLC, renal cancer, bladder cancer ...). Additional treatments may be administered between prior PD1/PDL1 blockade and inclusion in the study, but if administered immediately before, a minimum wash-out period of four weeks must be observed between both treatments.
- Patients must have received standard therapy, according to investigator´s criteria, or must be ineligible for standard therapy.
- Patients must present at least one tumor lesion that is amenable to perform sequential intratumoral therapy and biopsies.
- Measurable disease according to RECIST criteria. The measurable lesion(s) must be different than the lesion treated with intratumoral urelumab.
- There is no limit on previous treatment lines, as long as the other inclusion criteria are met.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy >12 weeks.
- Adequate organ function defined by:
- Bone Marrow Reserve: white blood cells (WBC): >=2000/ mm3 absolute neutrophil count (ANC) >=1500x 109/L; platelet count >=100000/ mm3 100 x 109/L; hemoglobin >=9.0 g/dL).
- Hepatic: bilirubin <1.5 times the upper limit of normality (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 x ULN (BR< 3 x ULN for patients with Gilbert´s Syndrome).
- Renal: creatinine <1.5 x ULN or estimated creatinine clearance > 40 ml/min, using the Cokcroft-Gault formula.
- Women of childbearing potential (WOCBP, i.e: fertile, following menarche and until becoming post-menopausal unless permanently sterile) must use a highly effective method to avoid pregnancy (i.e: combined estrogen and progestogen associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine device; intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence for 23 weeks (30 days plus the time required for nivolumab and urelumab to undergo five half-lives) after the last dose of investigational drug.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of treatment.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.
- Patients must be at least 18 years old.
Who cannot join
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy or interfere with the interpretation of study results. Special care should be taken with conditions affecting the liver.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- The treatment wash-out period for other previous therapies, including radiation therapy will be determined by the investigators, depending on resolution of associated toxicity. Limited-field palliative radiotherapy will not require a wash-out period. If PD1/PDL1 blockade is the previous therapy, a minimum wash-out period of four weeks must be observed between both treatments.
- Patients should be excluded if they have 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
- Active brain metastasis that may interfere with interpretation of results. Subjects with controlled metastasis will be allowed to enroll. Controlled brain metastases will be defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment.
- Pregnant or breastfeeding patients.
Show all 12Show fewer
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
- Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by Polymerase chain reaction (PCR) are eligible. History of resolved hepatitis A virus infection is not an exclusion criteria.
- History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
- Prisoners or subjects who are involuntarily incarcerated or who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Concomitant or prior malignancy that, in the opinion of the investigator can interfere with the results of the study, in the opinion of the investigator.
- Known drug or alcohol abuse.
Trial locations and contacts
2 sites in 1 country.
Mercedes Egaña, MD PhD contact
Spain2 sites
Clinica Universidad de Navarra
Madrid, 28022
Eduardo Castañón, MD PhD
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Jose L Perez Gracia, MD PhD
About this study
Open label, phase I-II study to evaluate the safety and activity of intratumoral urelumab combined with systemic nivolumab in patients with advanced solid tumors. Serial tumor and blood samples will be obtained during the study to characterize the changes induced by treatment in the tumor microenvironment, as well as predictive biomarkers of response.
- Conditions
- Neoplasms
- Being tested
- Urelumab + Nivolumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urelumab + NivolumabDrug
Treatment with intratumoral urelumab after which Nivolumab will be given.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Three doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg every 4 weeks (Q4W) from Cycle 3 and beyond Receives: Drug: Urelumab + Nivolumab |
| Cohort B | Experimental | Three doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg Q4W from Cycle 3 and beyond Receives: Drug: Urelumab + Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse events
Measured: 27 months
Recommended dose of intratumoral urelumab
mg of intratumoral urelumab
Measured: 12 weeks
Response rate
Number of patients with partial response or complete response
Measured: 27 months
Secondary outcomes (2)
Overall survival (OS).
Months until death
Measured: 27 months
Progression-free survival (PFS)
Months until progression
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start30 Jan 2019 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (142)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792724
- Sponsor's protocol ID
- INTRUST
- Acronym
- INTRUST
- Status last verified
- Nov 2018
- First submitted
- 20 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Coley, W. B. Late results of the treatment of inoperable sarcoma by the mixed toxins of erysipelas and bacillus prodigiosus. Am J Med Sci. 131: 375-430, 1906
Coley WB. The Treatment of Inoperable Sarcoma by Bacterial Toxins (the Mixed Toxins of the Streptococcus erysipelas and the Bacillus prodigiosus). Proc R Soc Med. 1910;3(Surg Sect):1-48. doi: 10.1177/003591571000301601. No abstract available.
PubMed 19974799Han RF, Pan JG. Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006 Jun;67(6):1216-23. doi: 10.1016/j.urology.2005.12.014.
PubMed 16765182Janeway CA Jr. The immune system evolved to discriminate infectious nonself from noninfectious self. Immunol Today. 1992 Jan;13(1):11-6. doi: 10.1016/0167-5699(92)90198-G.
PubMed 1739426Matzinger P. Friendly and dangerous signals: is the tissue in control? Nat Immunol. 2007 Jan;8(1):11-3. doi: 10.1038/ni0107-11.
PubMed 17179963Hammerich L, Binder A, Brody JD. In situ vaccination: Cancer immunotherapy both personalized and off-the-shelf. Mol Oncol. 2015 Dec;9(10):1966-81. doi: 10.1016/j.molonc.2015.10.016. Epub 2015 Nov 10.
PubMed 26632446Marabelle A, Kohrt H, Caux C, Levy R. Intratumoral immunization: a new paradigm for cancer therapy. Clin Cancer Res. 2014 Apr 1;20(7):1747-56. doi: 10.1158/1078-0432.CCR-13-2116.
PubMed 24691639Kaminski JM, Shinohara E, Summers JB, Niermann KJ, Morimoto A, Brousal J. The controversial abscopal effect. Cancer Treat Rev. 2005 May;31(3):159-72. doi: 10.1016/j.ctrv.2005.03.004.
PubMed 15923088Steinman RM. Decisions about dendritic cells: past, present, and future. Annu Rev Immunol. 2012;30:1-22. doi: 10.1146/annurev-immunol-100311-102839. Epub 2011 Nov 17.
PubMed 22136168Joffre OP, Segura E, Savina A, Amigorena S. Cross-presentation by dendritic cells. Nat Rev Immunol. 2012 Jul 13;12(8):557-69. doi: 10.1038/nri3254.
PubMed 22790179Inaba K, Turley S, Yamaide F, Iyoda T, Mahnke K, Inaba M, Pack M, Subklewe M, Sauter B, Sheff D, Albert M, Bhardwaj N, Mellman I, Steinman RM. Efficient presentation of phagocytosed cellular fragments on the major histocompatibility complex class II products of dendritic cells. J Exp Med. 1998 Dec 7;188(11):2163-73. doi: 10.1084/jem.188.11.2163.
PubMed 9841929Broz ML, Binnewies M, Boldajipour B, Nelson AE, Pollack JL, Erle DJ, Barczak A, Rosenblum MD, Daud A, Barber DL, Amigorena S, Van't Veer LJ, Sperling AI, Wolf DM, Krummel MF. Dissecting the tumor myeloid compartment reveals rare activating antigen-presenting cells critical for T cell immunity. Cancer Cell. 2014 Nov 10;26(5):638-52. doi: 10.1016/j.ccell.2014.09.007. Epub 2014 Oct 16.
PubMed 25446897Hildner K, Edelson BT, Purtha WE, Diamond M, Matsushita H, Kohyama M, Calderon B, Schraml BU, Unanue ER, Diamond MS, Schreiber RD, Murphy TL, Murphy KM. Batf3 deficiency reveals a critical role for CD8alpha+ dendritic cells in cytotoxic T cell immunity. Science. 2008 Nov 14;322(5904):1097-100. doi: 10.1126/science.1164206.
PubMed 19008445Schraml BU, Reis e Sousa C. Defining dendritic cells. Curr Opin Immunol. 2015 Feb;32:13-20. doi: 10.1016/j.coi.2014.11.001. Epub 2014 Dec 3.
PubMed 25553392Poulin LF, Salio M, Griessinger E, Anjos-Afonso F, Craciun L, Chen JL, Keller AM, Joffre O, Zelenay S, Nye E, Le Moine A, Faure F, Donckier V, Sancho D, Cerundolo V, Bonnet D, Reis e Sousa C. Characterization of human DNGR-1+ BDCA3+ leukocytes as putative equivalents of mouse CD8alpha+ dendritic cells. J Exp Med. 2010 Jun 7;207(6):1261-71. doi: 10.1084/jem.20092618. Epub 2010 May 17.
PubMed 20479117
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03792724
- Acronym / sponsor ID
- INTRUST / INTRUST
- Conditions
- Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 30 Jan 2019 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 3 Jan 2019 (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.
Open label, phase I-II study to evaluate the safety and activity of intratumoral urelumab combined with systemic nivolumab in patients with advanced solid tumors. Serial tumor and blood samples will be obtained during the study to characterize the changes induced by treatment in the tumor microenvironment, as well as predictive biomarkers of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Urelumab + NivolumabThree doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg every 4 weeks (Q4W) from Cycle 3 and beyond |
| Cohort B | Experimental | Drug: Urelumab + NivolumabThree doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg Q4W from Cycle 3 and beyond |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written informed consent.
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study.
- Patients must present the following tumor types:
- Patients must have received standard therapy, according to investigator´s criteria, or must be ineligible for standard therapy.
- Patients must present at least one tumor lesion that is amenable to perform sequential intratumoral therapy and biopsies.
Key exclusion criteria (12 listed)
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy or interfere with the interpretation of study results. Special care should be taken with conditions affecting the liver.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- The treatment wash-out period for other previous therapies, including radiation therapy will be determined by the investigators, depending on resolution of associated toxicity. Limited-field palliative radiotherapy will not require a wash-out period. If PD1/PDL1 blockade is the previous therapy, a minimum wash-out period of four weeks must be observed between both treatments.
- Patients should be excluded if they have 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
- Active brain metastasis that may interfere with interpretation of results. Subjects with controlled metastasis will be allowed to enroll. Controlled brain metastases will be defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment.
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 |
|---|---|---|
| Urelumab + NivolumabTreatment with intratumoral urelumab after which Nivolumab will be given. | Drug | Cohort A, Cohort B |
Primary outcome
Number of adverse events
Time frame: 27 months
Number of adverse events
Recommended dose of intratumoral urelumab
Time frame: 12 weeks
mg of intratumoral urelumab
Response rate
Time frame: 27 months
Number of patients with partial response or complete response
2 secondary outcomes
Overall survival (OS).
Time frame: 27 months
Progression-free survival (PFS)
Time frame: 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- BackgroundColey, W. B. Late results of the treatment of inoperable sarcoma by the mixed toxins of erysipelas and bacillus prodigiosus. Am J Med Sci. 131: 375-430, 1906
- Background: PubMed 19974799Coley WB. The Treatment of Inoperable Sarcoma by Bacterial Toxins (the Mixed Toxins of the Streptococcus erysipelas and the Bacillus prodigiosus). Proc R Soc Med. 1910;3(Surg Sect):1-48. doi: 10.1177/003591571000301601. No abstract available.
- Background: PubMed 16765182Han RF, Pan JG. Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006 Jun;67(6):1216-23. doi: 10.1016/j.urology.2005.12.014.
- Background: PubMed 1739426Janeway CA Jr. The immune system evolved to discriminate infectious nonself from noninfectious self. Immunol Today. 1992 Jan;13(1):11-6. doi: 10.1016/0167-5699(92)90198-G.
- Background: PubMed 17179963Matzinger P. Friendly and dangerous signals: is the tissue in control? Nat Immunol. 2007 Jan;8(1):11-3. doi: 10.1038/ni0107-11.
- Background: PubMed 26632446Hammerich L, Binder A, Brody JD. In situ vaccination: Cancer immunotherapy both personalized and off-the-shelf. Mol Oncol. 2015 Dec;9(10):1966-81. doi: 10.1016/j.molonc.2015.10.016. Epub 2015 Nov 10.
- Background: PubMed 24691639Marabelle A, Kohrt H, Caux C, Levy R. Intratumoral immunization: a new paradigm for cancer therapy. Clin Cancer Res. 2014 Apr 1;20(7):1747-56. doi: 10.1158/1078-0432.CCR-13-2116.
- Background: PubMed 15923088Kaminski JM, Shinohara E, Summers JB, Niermann KJ, Morimoto A, Brousal J. The controversial abscopal effect. Cancer Treat Rev. 2005 May;31(3):159-72. doi: 10.1016/j.ctrv.2005.03.004.
- Background: PubMed 22136168Steinman RM. Decisions about dendritic cells: past, present, and future. Annu Rev Immunol. 2012;30:1-22. doi: 10.1146/annurev-immunol-100311-102839. Epub 2011 Nov 17.
- Background: PubMed 22790179Joffre OP, Segura E, Savina A, Amigorena S. Cross-presentation by dendritic cells. Nat Rev Immunol. 2012 Jul 13;12(8):557-69. doi: 10.1038/nri3254.
- Background: PubMed 9841929Inaba K, Turley S, Yamaide F, Iyoda T, Mahnke K, Inaba M, Pack M, Subklewe M, Sauter B, Sheff D, Albert M, Bhardwaj N, Mellman I, Steinman RM. Efficient presentation of phagocytosed cellular fragments on the major histocompatibility complex class II products of dendritic cells. J Exp Med. 1998 Dec 7;188(11):2163-73. doi: 10.1084/jem.188.11.2163.
- Background: PubMed 25446897Broz ML, Binnewies M, Boldajipour B, Nelson AE, Pollack JL, Erle DJ, Barczak A, Rosenblum MD, Daud A, Barber DL, Amigorena S, Van't Veer LJ, Sperling AI, Wolf DM, Krummel MF. Dissecting the tumor myeloid compartment reveals rare activating antigen-presenting cells critical for T cell immunity. Cancer Cell. 2014 Nov 10;26(5):638-52. doi: 10.1016/j.ccell.2014.09.007. Epub 2014 Oct 16.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Mercedes Egaña, MD PhD contact
2 sites 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 Urelumab + Nivolumab in people with Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
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 21 inclusion and 12 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Jose L Perz Gracia, MD PhD (+34948255400, jlgracias@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 27 months). The study lists 3 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 NCT03792724, which also lists 142 linked publications.
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 3 Jan 2019.