CancerPhase 2NCT02938793
Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors
A Phase 2 study testing Durvalumab and Tremelimumab in people with Cancer and Rare Disease, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Rare Disease
- What is being tested?
- Durvalumab and Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 17 Sep 2025
- 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
- Diagnosis of a rare advanced solid malignancy meeting EORTC criteria.
- Subjects must have failed or been ineligible to receive standard treatment options if available.
- Subjects must be amenable to biopsy of a tumor site or have recent (< 2 years) archival material available.
- ECOG performance status of 0 to 2.
- Life expectancy > 3 months.
- Adequate normal organ and marrow function including: hemoglobin > 9.0 g/dl; ANC > 1500 per mm3; platelet count > 100,000 per mm3; bilirubin < 1.5 x ULN; ALT/AST < 2.5 x ULN unless liver metastases present in which case must be < 5 x ULN; creatinine clearance > 40 ml/min by Cockcroft-Gault or 24 hour urine collection
Who cannot join
- Previous treatment with durvalumab or tremelimumab.
- Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1).
- Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
- Untreated central nervous system metastatic disease.
- Active or documented autoimmune disease within previous 2 years.
- Uncontrolled psoriasis.
- Prior chemotherapy within 28 days of the first dose of durvalumab or tremelimumab.
- Steroid exposure within 28 days of the first dose of durvalumab or tremelimumab with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System Cancer Institute
Greenville, South Carolina, 29605
About this study
Official title: A Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Rare Solid Tumors
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors.
Read the detailed description
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors. The dose-exploration phase, conducted across a range of tumor types, has been completed. The dose-expansion phase is ongoing and includes certain soft tissue sarcomas, neuroendocrine tumors and thymic carcinoma. Therefore, subjects diagnosed with any of those rare tumors are excluded from this trial. Given the safety and tolerability data in the previous and ongoing studies (Study D4190C00010 and D4190C00006), the selected dose for evaluation in all subjects enrolled in this trial is as follows:
Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300 mg intravenously as a single dose on cycle 1 day 1 only. Weight-based dosing should be utilized for patients <30 kg: durvalumab 20 mg/kg and tremelimumab 1 mg/kg. Tremelimumab will be administered first and the infusion duration will be approximately 1 hour. The durvalumab infusion will start approximately 1 hour after the end of the tremelimumab infusion and the infusion will be administered over approximately 1 hour.
The project Surveillance of Rare Cancers in Europe (RARECARE) collected data on cancers from 89 population-based cancer registries in 21 European countries, making it possible to study the epidemiology of these cancers as a whole in a large and heterogeneous population. Working from this database and the literature, a RARECARE working group produced a new list of cancers and developed a new definition of rare cancers (incidence < 6/100,000/year). This definition and working list are adopted for this rare tumor immunotherapy study.
- Conditions
- Cancer, Rare Disease
- Being tested
- Durvalumab, Tremelimumab
- Keywords
- cancer, malignancy
- Medical subject headings
- Neoplasms, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
intravenous administration
TremelimumabDrug
Also called CP-675,206
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300mg intravenously as a single dose on cycle 1 day 1 only. Receives: Drug: Durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor Activity
To evaluate the antitumor activity of durvalumab in combination with tremelimumab based on immune-related Response Evaluation Criteria
Measured: 24 months
Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess the safety and tolerability of durvalumab in combination with tremelimumab
Measured: 24 months
Secondary outcomes (1)
Expression of programmed cell death protein 1 (PD-1)
To evaluate the pharmacodynamic activity of durvalumab in combination with tremelimumab in the tumor microenvironment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Why it stopped: poor enrollment likely due to expanded availability of immunotherapy for patients
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 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- William J Edenfield, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938793
- Sponsor's protocol ID
- ESR-15-11633
- Status last verified
- Apr 2025
- First submitted
- 10 Oct 2016
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: aggregate data only
Publications
Edenfield WJ, Chung K, O'Rourke M, Cull E, Martin J, Bowers H, Smith W, Gluck WL. A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers. Oncologist. 2021 Sep;26(9):e1499-e1507. doi: 10.1002/onco.13798. Epub 2021 May 8.
PubMed 33893692
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Rare Solid Tumors
- ClinicalTrials.gov ID
- NCT02938793
- Acronym / sponsor ID
- ESR-15-11633
- Conditions
- Cancer, Rare Disease
- Keywords
- cancer, malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment likely due to expanded availability of immunotherapy for patients
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- AstraZeneca, MedImmune LLC
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 19 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.
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors.
Detailed description
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors. The dose-exploration phase, conducted across a range of tumor types, has been completed. The dose-expansion phase is ongoing and includes certain soft tissue sarcomas, neuroendocrine tumors and thymic carcinoma. Therefore, subjects diagnosed with any of those rare tumors are excluded from this trial. Given the safety and tolerability data in the previous and ongoing studies (Study D4190C00010 and D4190C00006), the selected dose for evaluation in all subjects enrolled in this trial is as follows:
Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300 mg intravenously as a single dose on cycle 1 day 1 only. Weight-based dosing should be utilized for patients <30 kg: durvalumab 20 mg/kg and tremelimumab 1 mg/kg. Tremelimumab will be administered first and the infusion duration will be approximately 1 hour. The durvalumab infusion will start approximately 1 hour after the end of the tremelimumab infusion and the infusion will be administered over approximately 1 hour.
The project Surveillance of Rare Cancers in Europe (RARECARE) collected data on cancers from 89 population-based cancer registries in 21 European countries, making it possible to study the epidemiology of these cancers as a whole in a large and heterogeneous population. Working from this database and the literature, a RARECARE working group produced a new list of cancers and developed a new definition of rare cancers (incidence < 6/100,000/year). This definition and working list are adopted for this rare tumor immunotherapy study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Durvalumab, Drug: TremelimumabDurvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300mg intravenously as a single dose on cycle 1 day 1 only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of a rare advanced solid malignancy meeting EORTC criteria.
- Subjects must have failed or been ineligible to receive standard treatment options if available.
- Subjects must be amenable to biopsy of a tumor site or have recent (< 2 years) archival material available.
- ECOG performance status of 0 to 2.
- Life expectancy > 3 months.
Key exclusion criteria (8 listed)
- Previous treatment with durvalumab or tremelimumab.
- Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1).
- Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
- Untreated central nervous system metastatic disease.
- Active or documented autoimmune disease within previous 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736intravenous administration | Drug | Single Arm |
| TremelimumabAlso: CP-675,206intravenous administration | Drug | Single Arm |
Primary outcome
Antitumor Activity
Time frame: 24 months
To evaluate the antitumor activity of durvalumab in combination with tremelimumab based on immune-related Response Evaluation Criteria
Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 24 months
To assess the safety and tolerability of durvalumab in combination with tremelimumab
1 secondary outcome
Expression of programmed cell death protein 1 (PD-1)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: poor enrollment likely due to expanded availability of immunotherapy for patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 33893692Edenfield WJ, Chung K, O'Rourke M, Cull E, Martin J, Bowers H, Smith W, Gluck WL. A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers. Oncologist. 2021 Sep;26(9):e1499-e1507. doi: 10.1002/onco.13798. Epub 2021 May 8.
- Individual participant dataSharing planned: No. aggregate data only
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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.
William J Edenfield, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Tremelimumab in people with Cancer and Rare Disease, run by Prisma Health-Upstate 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 6 inclusion and 8 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 23 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor enrollment likely due to expanded availability of immunotherapy for patients). 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?
Antitumor Activity (time frame: 24 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 NCT02938793, 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 23 Sep 2025.