Metastatic Ovarian CancerPhase 1/2NCT04611126
T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer
A Phase 1/2 study testing Ipilimumab, Cyclophosphamid and Fludarabine Phosphate in people with Metastatic Ovarian Cancer and Metastatic Fallopian Tube Cancer, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances. In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Ovarian Cancer, Metastatic Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Ipilimumab, Cyclophosphamid and Fludarabine Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2021to 3 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proven advanced ovarian-, fallopian tube or primary peritoneal cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. All histologies can be included.
- Progressive or recurrent resistant disease after platin-based chemotherapy (platinum resistant) or progressive or recurrent disease after second line or additional chemotherapy.
- Age: 18 - 75 years.
- ECOG performance status of ≤1 (Appendix 2).
- Life expectancy of > 6 months.
- At least one measurable parameter in accordance with RECIST 1.1 -criteria.
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- LVEF assessment with documented LVEF ≥50% by either TTE or MUGA (TTE preferred test) within 6 months from first study drug administration
- No significant toxicities or side effects (CTC ≤ 1) from previous treatments, except sensory- and motoric neuropathy (CTC ≤ 2) and/or alopecia (CTC ≤ 2).
- Sufficient organ function, including:
- Absolute neutrophil count (ANC) ≥ 1.500 /µl
- Leucocyte count ≥ lower normal limit
- Platelets ≥ 100.000 /µl and <700.000 /µl
- Hemoglobin ≥ 6,0 mmol/l (regardless of prior transfusion)
- S-creatinine < 140
- S-bilirubin ≤ 1,5 times upper normal limit
- ASAT/ALAT ≤ 2,5 times upper normal limit
- Alkaline phosphatase ≤ 5 times upper normal limit
- Lactate dehydrogenase ≤ 5 times upper normal limit
- Sufficient coagulation: APPT<40 and INR<1,5
- Signed statement of consent after receiving oral and written study information
- Willingness to participate in the planned controls and capable of handling toxicities.
- Age and Reproductive Status: Females, ages ≥18 years, inclusive
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study treatment.Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception. This applies from inclusion in the study and for the duration of treatment with Ipilimumab, Relatlimab and Nivolumab plus 5 half-lives of study treatment plus 30 days (duration of ovulatory cycle) for a total of 24 weeks post-treatment completion. The following are considered safe methods of contraception:
- Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch)
- Intrauterine device
- Surgical sterilization
- Surgical sterilization of male partner with verification of no sperm after the procedure
- Menopause (for more than 12 months)
Who cannot join
- Patients will be excluded if they meet one of the criteria's listed below
- A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
- Known hypersensitivity to one of the active drugs or one or more of the excipients.
- Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.
- Creatinine clearance < 70 ml/min (1).
- Acute/chronic infection with HIV, hepatitis, syphilis among others.
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- Severe allergies or previous anaphylactic reactions.
- Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren's syndrome, sclerodermia, myasthenia gravis, Goodpasteur's disease, Addison's disease, Hashimotos thyroiditis, active Graves disease.
- Subjects with history of myocarditis, regardless of etiology
- Troponin T (TnT) or I (TnI) > 2x institutional upper limit of normal (ULN) is excluded. ii) between > 1 to 2 x ULN will be permitted if a repeat assessment remains ≤ 2 x ULN and participant undergoes a cardiac evaluation and is cleared by a cardiologist or cardio-oncologist
- Prior treatment with LAG-3 targeted agents.
- Pregnant women and women breastfeeding.
- Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others) (2).
- Simultaneous treatment with other experimental drugs. Based on clinical judgement antihormonal treatment can be accepted.
- Simultaneous treatment with other systemic anti-cancer treatments.
- Patients with active and uncontrollable hypercalcemia
- (1)In selected cases it can be decided to include a patient with a GFR < 70 ml/min with the use of a reduced dose of chemotherapy.
- (2)In selected cases a systemic dose of ≤10 mg prednisolone or a transient planned treatment that can be stopped before TIL therapy can be tolerated.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Center for Cancer Immune Therapy (CCIT-DK)
Herlev, 2730
About this study
Official title: T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer
Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances.
In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed.
Read more
Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function.
In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction.
With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).
Read the detailed description
Rationale T-cell therapy is an experimental personalized immunotherapy where TILs are isolated from the patient's own tumor tissue, expanded in vitro to billions of cells and then administered to the individual patient with the purpose of eliminating the remaining cancer cells. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine phosphate is administered to the patient before TIL infusion to reduce the number of irrelevant immune cells.
In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), it has been shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab.
Between 90-100% of infused T-cells in these previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function.
In this phase I/II study 18 patients with advanced ovarian -, fallopian tube-, and primary peritoneal cancer will be included. Included patients undergo surgical removal of tumor tissue for tumor-infiltrating lymphocyte (TIL) manufacturing. Lymphodepleting chemotherapy is administered prior to TIL infusion. Hereafter the patients are treated with the programmed cell death protein 1 (PD-1) antibody Nivolumab and the anti-lymphocyte activation gene 3 (anti-LAG-3) antibody Relatlimab. The study will be divided into 3 steps.
- Step One (6 subjects): Patients are treated without prior administration of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody Ipilimumab pre-tumor harvest.
- Step Two (6 subjects): If Step One proves feasible and tolerable patients in Step Two will receive one dose of Ipilimumab pre-tumor harvest.
- Step Three (6 subjects): Patients are treated either with or without prior Ipilimumab pre-tumor harvest depending on the tolerability data from Step Two.
All patients are treated with lymphodepleting chemotherapy for 7 days followed by infusion of TILs. For safety reasons no IL-2- will be administered in this study
The aim of this study is to demonstrate that ACT and a combination of Relatlimab-Nivolumab does not increase the toxicity compared to the same treatment regimen including Nivolumab monotherapy. The study will elucidate whether the combination Relatlimab-Nivolumab lead to objective responses and improves progression free survival (PFS). It is anticipated that combining Relatlimab and Nivolumab with Adoptive T cell therapy (ACT) for advanced OC is safe and feasible. Further, it is hypothesized that the combination will lead to improved immunity in tumor and blood as well as improved antitumor efficacy.
Objectives
- To evaluate the tolerability and safety of the treatment
- To characterize antitumor immune responses and clinical efficacy
- Being tested
- Ipilimumab, Cyclophosphamid, Fludarabine Phosphate, Tumor Infiltrating Lymphocytes infusion, Nivolumab
- Keywords
- Adoptive Cell Therapy, Immune Therapy, Tumor Infiltrating Lymphocytes
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Ipilimumab 3 mg/kg is administered 2-6 weeks before surgical removement of the tumor. The medicine is administered i.v. over 30 minutes.
CyclophosphamidDrug
Also called Cyclophosphamide
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Tumor Infiltrating Lymphocytes infusionBiological
Also called TILs
Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
NivolumabDrug
Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
RelatlimabDrug
Also called Relalimab
Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Without Ipilimumab | Other | At Step 1, 6 patients will be treated without Ipilimumab pre tumor harvest. If feasible and tolerable, as defined by no additional SAE/SAR compared to the previously completed pilot studies at CCIT-DK, the trial will move to Step 2.
Depending on the safety and feasibility on step 2, 6 more patients can be included at step 1. Receives: Drug: Cyclophosphamid; Drug: Fludarabine Phosphate; Biological: Tumor Infiltrating Lymphocytes infusion; Drug: Nivolumab; Drug: Relatlimab |
| With Ipilimumab | Other | At Step 2, 6 patients will be included. Ipilimumab 3 mg/kg will be administered 2-6 weeks pre tumor harvest.
If no additional SAE/SAR compared to the previous completed pilot study at CCIT-DK is observed additional 6 patients can be included at Step 2. If on the other hand Step 2is not found safe additional 6 patients can be included at Step 1 Receives: Drug: Ipilimumab; Drug: Cyclophosphamid; Drug: Fludarabine Phosphate; Biological: Tumor Infiltrating Lymphocytes infusion; Drug: Nivolumab; Drug: Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Excluded Due to Treatment Related Safety Issues
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study
Measured: Until completion of the study for
Number of Participants Experiencing Grade III or Worse Adverse Events
The number of Participants Experiencing Grade III or Worse Adverse Events
Measured: Until completion of the study
Number of Patients Excluded Due to Feasibility Issues
Number of patients excluded due to feasibility issues compared to the number of patients enrolled in the study
Measured: Until completion of the study
Secondary outcomes (1)
Best Overall Response (BOR)
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR.
Measured: The patients were evaluated every 6-12 weeks after therapy and until study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start22 Apr 2021
- Primary completion3 Mar 2024
- Study completion3 Mar 2024
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Ovarian 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 18 patients are included in 3 steps, containing 6 patients each. Step 1: 6 patients will be included. Ipilimumab wil not be administered pre-tumor harvest. If feasible and tolerable, as defined by no additional SAE/SAR compared to the previously completed pilot studies at CCIT-DK, the trial will move to Step 2 Step 2: 6 patients will be included. Ipilimumab will be administered once 2-6 weeks before tumor resection. Step 3: If no additional SAE/SAR, compared to the previous completed study at CCIT-DK, is observed additional 6 patients can be included at Step Two. If on the other hand Step 2 is not found safe, additional 6 patients can be included at Step 1
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Inge Marie Svane, Prof., M.D., Study director, Study Director, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital HerlevTine J Monberg, M.D., Study director, Clinical Assistant, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611126
- Sponsor's protocol ID
- GY2028
- Status last verified
- Aug 2025
- First submitted
- 20 Oct 2020
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT04611126
- Acronym / sponsor ID
- GY2028
- Keywords
- Adoptive Cell Therapy, Immune Therapy, Tumor Infiltrating Lymphocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances.
In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed.
Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function.
In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction.
With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).
Detailed description
Rationale T-cell therapy is an experimental personalized immunotherapy where TILs are isolated from the patient's own tumor tissue, expanded in vitro to billions of cells and then administered to the individual patient with the purpose of eliminating the remaining cancer cells. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine phosphate is administered to the patient before TIL infusion to reduce the number of irrelevant immune cells.
In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), it has been shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab.
Between 90-100% of infused T-cells in these previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function.
In this phase I/II study 18 patients with advanced ovarian -, fallopian tube-, and primary peritoneal cancer will be included. Included patients undergo surgical removal of tumor tissue for tumor-infiltrating lymphocyte (TIL) manufacturing. Lymphodepleting chemotherapy is administered prior to TIL infusion. Hereafter the patients are treated with the programmed cell death protein 1 (PD-1) antibody Nivolumab and the anti-lymphocyte activation gene 3 (anti-LAG-3) antibody Relatlimab. The study will be divided into 3 steps.
- Step One (6 subjects): Patients are treated without prior administration of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody Ipilimumab pre-tumor harvest.
- Step Two (6 subjects): If Step One proves feasible and tolerable patients in Step Two will receive one dose of Ipilimumab pre-tumor harvest.
- Step Three (6 subjects): Patients are treated either with or without prior Ipilimumab pre-tumor harvest depending on the tolerability data from Step Two.
All patients are treated with lymphodepleting chemotherapy for 7 days followed by infusion of TILs. For safety reasons no IL-2- will be administered in this study
The aim of this study is to demonstrate that ACT and a combination of Relatlimab-Nivolumab does not increase the toxicity compared to the same treatment regimen including Nivolumab monotherapy. The study will elucidate whether the combination Relatlimab-Nivolumab lead to objective responses and improves progression free survival (PFS). It is anticipated that combining Relatlimab and Nivolumab with Adoptive T cell therapy (ACT) for advanced OC is safe and feasible. Further, it is hypothesized that the combination will lead to improved immunity in tumor and blood as well as improved antitumor efficacy.
Objectives
- To evaluate the tolerability and safety of the treatment
- To characterize antitumor immune responses and clinical efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 18 patients are included in 3 steps, containing 6 patients each. Step 1: 6 patients will be included. Ipilimumab wil not be administered pre-tumor harvest. If feasible and tolerable, as defined by no additional SAE/SAR compared to the previously completed pilot studies at CCIT-DK, the trial will move to Step 2 Step 2: 6 patients will be included. Ipilimumab will be administered once 2-6 weeks before tumor resection. Step 3: If no additional SAE/SAR, compared to the previous completed study at CCIT-DK, is observed additional 6 patients can be included at Step Two. If on the other hand Step 2 is not found safe, additional 6 patients can be included at Step 1
| Arm | Type | Receives |
|---|---|---|
| Without Ipilimumab | Other | Drug: Cyclophosphamid, Drug: Fludarabine Phosphate, Biological: Tumor Infiltrating Lymphocytes infusion, Drug: Nivolumab, Drug: RelatlimabAt Step 1, 6 patients will be treated without Ipilimumab pre tumor harvest. If feasible and tolerable, as defined by no additional SAE/SAR compared to the previously completed pilot studies at CCIT-DK, the trial will move to Step 2. Depending on the safety and feasibility on step 2, 6 more patients can be included at step 1. |
| With Ipilimumab | Other | Drug: Ipilimumab, Drug: Cyclophosphamid, Drug: Fludarabine Phosphate, Biological: Tumor Infiltrating Lymphocytes infusion, Drug: Nivolumab, Drug: RelatlimabAt Step 2, 6 patients will be included. Ipilimumab 3 mg/kg will be administered 2-6 weeks pre tumor harvest. If no additional SAE/SAR compared to the previous completed pilot study at CCIT-DK is observed additional 6 patients can be included at Step 2. If on the other hand Step 2is not found safe additional 6 patients can be included at Step 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histological proven advanced ovarian-, fallopian tube or primary peritoneal cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. All histologies can be included.
- Progressive or recurrent resistant disease after platin-based chemotherapy (platinum resistant) or progressive or recurrent disease after second line or additional chemotherapy.
- Age: 18 - 75 years.
- ECOG performance status of ≤1 (Appendix 2).
- Life expectancy of > 6 months.
Key exclusion criteria (18 listed)
- Patients will be excluded if they meet one of the criteria's listed below
- A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
- Known hypersensitivity to one of the active drugs or one or more of the excipients.
- Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.
- Creatinine clearance < 70 ml/min (1).
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 |
|---|---|---|
| IpilimumabIpilimumab 3 mg/kg is administered 2-6 weeks before surgical removement of the tumor. The medicine is administered i.v. over 30 minutes. | Drug | With Ipilimumab |
| CyclophosphamidAlso: CyclophosphamideCyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6. | Drug | With Ipilimumab, Without Ipilimumab |
| Fludarabine PhosphateFludarabine 25 mg/m2 is administered on day -5 to day -1. | Drug | With Ipilimumab, Without Ipilimumab |
| Tumor Infiltrating Lymphocytes infusionAlso: TILsTumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0. | Biological | With Ipilimumab, Without Ipilimumab |
| NivolumabNivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes. | Drug | With Ipilimumab, Without Ipilimumab |
| RelatlimabAlso: RelalimabRelatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes. | Drug | With Ipilimumab, Without Ipilimumab |
Primary outcome
Number of Patients Excluded Due to Treatment Related Safety Issues
Time frame: Until completion of the study for
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study
Number of Participants Experiencing Grade III or Worse Adverse Events
Time frame: Until completion of the study
The number of Participants Experiencing Grade III or Worse Adverse Events
Number of Patients Excluded Due to Feasibility Issues
Time frame: Until completion of the study
Number of patients excluded due to feasibility issues compared to the number of patients enrolled in the study
1 secondary outcome
Best Overall Response (BOR)
Time frame: The patients were evaluated every 6-12 weeks after therapy and until study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Inge Marie Svane, Prof., M.D. study director
Study Director, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
Tine J Monberg, M.D. study director
Clinical Assistant, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
1 site 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 Ipilimumab, Cyclophosphamid and Fludarabine Phosphate in people with Metastatic Ovarian Cancer and Metastatic Fallopian Tube Cancer, run by Inge Marie Svane at 1 site in Denmark.
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 28 inclusion and 18 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 12 Aug 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Excluded Due to Treatment Related Safety Issues (time frame: Until completion of the study for). 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?
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 12 Aug 2025.