Gastrointestinal CancerPhase 2NCT02923934
A Phase II Trial of Ipilimumab and Nivolumab for the Treatment of Rare Cancers
A Phase 2 study testing Ipilimumab and Nivolumab in people with Gastrointestinal Cancer and Neuroendocrine Tumours, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.
Trial summary
The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Neuroendocrine Tumours, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Ipilimumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesAustralia
- Study dates
- 22 Aug 2017to 12 Dec 2023
- 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
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Target Population
- Histologically confirmed Upper GI malignancies (Cholangiocarcinoma/ duodenal carcinoma - collect MSI (microsatellite instability) status); Neuroendocrine tumours (inc. pancreatic, bronchial and intestinal carcinoid tumours) and Rare Gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed Mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours).
- Eastern Cooperative Oncology Group (ECOG) performance status of 1
- Prior systemic therapy is permitted if it was completed at least 4 weeks prior to enrolment, and all related adverse events have either returned to baseline or stabilized or subjects are not suitable for, or if declining established standard therapies.
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- Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration.
- Measurable disease by CT or MRI per RECIST 1.1 criteria
- Tumour tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. If an insufficient amount of tumour tissue from an unresectable or metastatic site is available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumour tissue for performance of biomarker analyses.
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:
- WBC (white blood cells) > or = to 2000/μL
- Neutrophils > or = to 1500/μL
- Platelets > or = to 100 x103/μL
- Hemoglobin > 9.0 g/dL
- Serum creatinine < or = to 1.5 x ULN or creatinine clearance (CrCl) 40 mL/min (using the Cockcroft-Gault formula)
- AST/ALT (aspartate transaminase/alanine transaminase) < or = to 3 x ULN
- Total Bilirubin < or = to 1.5 x ULN (Upper limit of normal) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
- Subject Re-enrolment: This study permits the re-enrolment of a subject that has discontinued the study as a pre-treatment failure (i.e. subject has not been treated) after obtaining agreement from the medical monitor prior to re enrolling a subject. If re-enrolled, the subject must be re-consented.
- Age and Reproductive Status
- Men and women, > or = to 18 years of age
- Women of childbearing potential (WOCBP) must use method(s) of contraception. WOCBP should therefore use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for Nivolumab to undergo five half lives) after the last dose of investigational drug.
- Women 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 investigational product.
- Women must not be breastfeeding
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1 percent per year. Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half lives. The half life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. Given the blinded nature of the study, men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half lives) after the last dose of investigational drug.
- Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile and azoospermic men do not require contraception.
Who cannot join
- Target Disease Exceptions
- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI except where contraindicated in which CT scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Cases should be discussed with the medical monitor. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- Medical History and Concurrent Diseases
- Prior combination treatment directed against the PD-1/PDL1 (Programmed Death Ligand 1) axis (anti PD 1, anti PD-L1, anti PD L2), and anti CTLA 4 antibody. Prior monotherapy with these agents or other immune-stimulating/regulating agents is permitted.
- 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 protocol therapy, or interfere with the interpretation of study results.
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
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- 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.
- Subjects with 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.
- Physical and Laboratory Test Findings
- Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Allergies and Adverse Drug Reaction
- History of allergy to study drug components.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Sex and Reproductive Status
- WOCBP who are pregnant or breastfeeding
- Women with a positive pregnancy test at enrolment or prior to administration of study medication.
- Other Exclusion Criteria
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Border Medical Oncology Unit
Albury, New South Wales, 2640
Monash Health
Clayton, Victoria, 3168
Austin Health
Heidelberg, Victoria, 3078
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Blacktown Hospital
Sydney, New South Wales, 2145
About this study
Official title: A Phase II Clinical Trial Evaluating Ipilimumab and Nivolumab in Combination for the Treatment of Rare Gastrointestinal, Neuro-Endocrine and Gynaecological Cancers
The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours).
The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined.
This protocol provides an important opportunity to establish whether the combination of nivolumab \& ipilimumab has efficacy in these cancers.
Read the detailed description
This is a phase 2 clinical trial of nivolumab combined with ipilimumab in subjects with rare cancers. This study will allow an evaluation of the clinical benefit, as measured by progression free survival (PFS) and overall survival (OS), provided by nivolumab combined with ipilimumab. If the safety profile is acceptable and clinically efficacy is seen, this study would support the use of nivolumab combined with ipilimumab in subjects with these cancers.
Study Rationale Clinically advanced rare cancers pose a significant clinical challenge because evidence based treatments are seldom available for patients suffering from these malignancies. Despite little evidence that shows clinical benefit, these patients are often treated with chemotherapeutic agents that are used in patients with more common malignancies that arise from the same anatomical site. Furthermore, because of small numbers, they are often excluded from clinical trials with newer agents. The rare care project has defined a rare malignancy as a cancer with an incidence of less than 6/100000/year. It is estimated that 42,000 people are diagnosed with a form of rare or less common cancer in Australia every year (www.canceraustralia.gov.au). The cancer specific survival of patients diagnosed with a rare malignancy is significantly lower than with common cancers highlighting the need to improve management and treatment of these patients. Given the recent success of cancer immunotherapy with checkpoint regulators such as ipilimumab and nivolumab in a whole range of different cancer types, it can be postulated that these agents could be beneficial in rare cancers and improve the overall outlook of patients with these conditions. It is proposed here that patient cohorts which fall within three distinct tumour streams will be examined, with all patients receiving ipilimumab and nivolumab as combination immunotherapy. The three tumour streams are defined as: upper GI malignancies (comprising intra-hepatic/ extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours). Although overall response rates for individual tumour types will not be established due to sample size (target 20 patients per tumour stream, n=60 total), descriptive information of individual patient responses will guide immune-directed therapies to responsive rare tumour types and may be broadened to tumour streams.
- Conditions
- Gastrointestinal Cancer, Neuroendocrine Tumours, Malignant Female Reproductive System Neoplasm
- Being tested
- Ipilimumab, Nivolumab
- Medical subject headings
- Gastrointestinal Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called YERVOY ®
CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) is a key regulator of T cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of tumor reactive T effector cells which mobilize to mount a direct T-cell immune attack against tumor cells. CTLA-4 blockade can also reduce T regulatory cell function, which may lead to an increase in anti-tumor immune response.
NivolumabDrug
Also called Opdivo
A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1,PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and and plays a key role in in tumor evasion from host immunity.
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab and Nivolumab | Experimental | All Subjects will be treated with: Nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg concurrently every 3 weeks for 4 doses followed by nivolumab only at 3mg/kg every 2 weeks until progression (up to 48 total doses of nivolumab) Receives: Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the clinical efficacy of the combination treatment of ipilimumab with nivolumab in rare cancers.
Clinical benefit rate for whole population (CR (complete response)+PR (partial response)+SD (stable disease)>3 months)
Measured: at 12 weeks following randomisation then every 6 weeks until disease progression
Secondary outcomes (1)
To identify whether a common predictive biomarker or immune signature can be identified in responding patients that can occur irrespective of tumour type.
Pre-dose Blood and Serum samples on Day 1 week 1 and Day 1 week 4 for cycle 1 and Day 1 week 1 for cycle 2 (each cycle is 6 weeks). Optional tumour biopsies will be assessed at Day 1 week 1 and Day 1 week 4 for both cycles 1 and 2.
Measured: Pre-dose samples will be collected during the first two cycles (6 weeks/cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start22 Aug 2017
- Primary completion27 Apr 2020
- Study completion12 Dec 2023
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 Gastrointestinal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Study chair, ONJCRI and Austin HealthJonathan Cebon, MD, Study chair, ONJCRI and Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923934
- Sponsor's protocol ID
- ONJ2016-001
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2016
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Publications
Klein O, Kee D, Nagrial A, Markman B, Underhill C, Michael M, Jackett L, Lum C, Behren A, Palmer J, Tebbutt NC, Carlino MS, Cebon J. Evaluation of Combination Nivolumab and Ipilimumab Immunotherapy in Patients With Advanced Biliary Tract Cancers: Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1405-1409. doi: 10.1001/jamaoncol.2020.2814.
PubMed 32729929
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating Ipilimumab and Nivolumab in Combination for the Treatment of Rare Gastrointestinal, Neuro-Endocrine and Gynaecological Cancers
- ClinicalTrials.gov ID
- NCT02923934
- Acronym / sponsor ID
- ONJ2016-001
- Conditions
- Gastrointestinal Cancer, Neuroendocrine Tumours, Malignant Female Reproductive System Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 5 Oct 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 three tumour streams that will be studied in this protocol are: (i) upper GI malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours).
The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined.
This protocol provides an important opportunity to establish whether the combination of nivolumab \& ipilimumab has efficacy in these cancers.
Detailed description
This is a phase 2 clinical trial of nivolumab combined with ipilimumab in subjects with rare cancers. This study will allow an evaluation of the clinical benefit, as measured by progression free survival (PFS) and overall survival (OS), provided by nivolumab combined with ipilimumab. If the safety profile is acceptable and clinically efficacy is seen, this study would support the use of nivolumab combined with ipilimumab in subjects with these cancers.
Study Rationale Clinically advanced rare cancers pose a significant clinical challenge because evidence based treatments are seldom available for patients suffering from these malignancies. Despite little evidence that shows clinical benefit, these patients are often treated with chemotherapeutic agents that are used in patients with more common malignancies that arise from the same anatomical site. Furthermore, because of small numbers, they are often excluded from clinical trials with newer agents. The rare care project has defined a rare malignancy as a cancer with an incidence of less than 6/100000/year. It is estimated that 42,000 people are diagnosed with a form of rare or less common cancer in Australia every year (www.canceraustralia.gov.au). The cancer specific survival of patients diagnosed with a rare malignancy is significantly lower than with common cancers highlighting the need to improve management and treatment of these patients. Given the recent success of cancer immunotherapy with checkpoint regulators such as ipilimumab and nivolumab in a whole range of different cancer types, it can be postulated that these agents could be beneficial in rare cancers and improve the overall outlook of patients with these conditions. It is proposed here that patient cohorts which fall within three distinct tumour streams will be examined, with all patients receiving ipilimumab and nivolumab as combination immunotherapy. The three tumour streams are defined as: upper GI malignancies (comprising intra-hepatic/ extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours). Although overall response rates for individual tumour types will not be established due to sample size (target 20 patients per tumour stream, n=60 total), descriptive information of individual patient responses will guide immune-directed therapies to responsive rare tumour types and may be broadened to tumour streams.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab and Nivolumab | Experimental | Drug: Ipilimumab, Drug: NivolumabAll Subjects will be treated with: Nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg concurrently every 3 weeks for 4 doses followed by nivolumab only at 3mg/kg every 2 weeks until progression (up to 48 total doses of nivolumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Signed Written Informed Consent
- Target Population
- Age and Reproductive Status
Key exclusion criteria (20 listed)
- Target Disease Exceptions
- Medical History and Concurrent Diseases
- Physical and Laboratory Test Findings
- Allergies and Adverse Drug Reaction
- Sex and Reproductive Status
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 |
|---|---|---|
| IpilimumabAlso: YERVOY ®CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) is a key regulator of T cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of tumor reactive T effector cells which mobilize to mount a direct T-cell immune attack against tumor cells. CTLA-4 blockade can also reduce T regulatory cell function, which may lead to an increase in anti-tumor immune response. | Drug | Ipilimumab and Nivolumab |
| NivolumabAlso: OpdivoA fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1,PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and and plays a key role in in tumor evasion from host immunity. | Drug | Ipilimumab and Nivolumab |
Primary outcome
To determine the clinical efficacy of the combination treatment of ipilimumab with nivolumab in rare cancers.
Time frame: at 12 weeks following randomisation then every 6 weeks until disease progression
Clinical benefit rate for whole population (CR (complete response)+PR (partial response)+SD (stable disease)>3 months)
1 secondary outcome
To identify whether a common predictive biomarker or immune signature can be identified in responding patients that can occur irrespective of tumour type.
Time frame: Pre-dose samples will be collected during the first two cycles (6 weeks/cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 32729929Klein O, Kee D, Nagrial A, Markman B, Underhill C, Michael M, Jackett L, Lum C, Behren A, Palmer J, Tebbutt NC, Carlino MS, Cebon J. Evaluation of Combination Nivolumab and Ipilimumab Immunotherapy in Patients With Advanced Biliary Tract Cancers: Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1405-1409. doi: 10.1001/jamaoncol.2020.2814.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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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.
Oliver Klein, MD study chair
ONJCRI and Austin Health
Jonathan Cebon, MD study chair
ONJCRI and Austin Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab and Nivolumab in people with Gastrointestinal Cancer and Neuroendocrine Tumours, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.
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 25 inclusion and 20 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the clinical efficacy of the combination treatment of ipilimumab with nivolumab in rare cancers. (time frame: at 12 weeks following randomisation then every 6 weeks until disease progression). 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 NCT02923934, 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 24 Jul 2024.