Floatz Rating
BB64/100
Confidence
Indicative
Sponsor
East Metropolitan Health Service, Australia
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
59High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07651618CT.gov A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma | — | Not Yet Recruiting | — | — | — |
NCT06626256CT.gov STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma | — | Withdrawn | — | — | — |
NCT04119024CT.gov Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT06961786CT.gov TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma | — | Active Not Recruiting | — | — | — |
NCT06889766CT.gov NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma | — | Recruiting | — | — | — |
NCT06151847CT.gov Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma | — | Completed | — | — | — |
NCT06060613CT.gov Safety and Efficacy of OBX-115 in Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05628883CT.gov Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma | — | Completed | — | — | — |
NCT05470283CT.gov Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma | — | Active Not Recruiting | — | — | — |
NCT05361174CT.gov A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer | — | Recruiting | — | — | — |
Show 42 more trialsShow fewer
NCT05176470CT.gov Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients | — | Active Not Recruiting | — | — | — |
NCT03475134CT.gov TIL-ACT After NMA Chemo with IL-2 and Nivo Rescue in Metastatic Melanoma (mMEL) | — | Completed | — | — | — |
NCT03526185CT.gov A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes | — | Terminated | — | — | — |
NCT02500576CT.gov Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT02489266CT.gov In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma | — | Withdrawn | — | — | — |
NCT01740557CT.gov Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or Metastatic Melanoma | — | Completed | — | — | — |
NCT02379195CT.gov Peginterferon and TIL Therapy for Metastatic Melanoma | — | Completed | — | — | — |
NCT02354690CT.gov Vemurafenib and TIL Therapy for Metastatic Melanoma | — | Completed | — | — | — |
NCT01955460CT.gov Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma | — | Active Not Recruiting | — | — | — |
NCT02278887CT.gov Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01995344CT.gov TIL Therapy in Metastatic Melanoma and IL2 Dose Assessment | — | Terminated | — | — | — |
NCT02062359CT.gov T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Melanoma | — | Terminated | — | — | — |
NCT01993719CT.gov Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01807182CT.gov Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01883323CT.gov Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy Following Cyclophosphamide And Fludarabine In Patients With Melanoma | — | Completed | — | — | — |
NCT01701674CT.gov Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts | — | Completed | — | — | — |
NCT01659151CT.gov Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma | — | Completed | — | — | — |
NCT01339663CT.gov Vaccine Therapy Following Therapeutic Autologous Lymphocytes and Cyclophosphamide in Treating Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT01495572CT.gov Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells | — | Terminated | — | — | — |
NCT01468818CT.gov Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma | — | Terminated | — | — | — |
NCT01369875CT.gov Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma | — | Terminated | — | — | — |
NCT01369888CT.gov Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma | — | Terminated | — | — | — |
NCT01319565CT.gov Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI... | — | Completed | — | — | — |
NCT01273181CT.gov MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes | — | Terminated | — | — | — |
NCT01218867CT.gov CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer | — | Terminated | — | — | — |
NCT01236573CT.gov Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes | — | Terminated | — | — | — |
NCT01106235CT.gov Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Metastatic Melanoma | — | Terminated | — | — | — |
NCT01005745CT.gov Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma | — | Completed | — | — | — |
NCT00910650CT.gov Study of Gene Modified Immune Cells in Patients With Advanced Melanoma | — | Completed | — | — | — |
NCT00945269CT.gov Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma | — | Terminated | — | — | — |
NCT00604136CT.gov Treatment of Metastatic Melanoma With Tumor Infiltrating Lymphocytes and IL-2 Following Lympho-depleting Chemotherapy | — | Unknown | — | — | — |
NCT00670748CT.gov Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer | — | Terminated | — | — | — |
NCT00612222CT.gov Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma | — | Terminated | — | — | — |
NCT00610311CT.gov Anti-gp100 Cells Plus ALVAC gp100 Vaccine to Treat Advanced Melanoma | — | Terminated | — | — | — |
NCT00553306CT.gov Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma | — | Completed | — | — | — |
NCT00924001CT.gov Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma | — | Terminated | — | — | — |
NCT00513604CT.gov Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma | — | Completed | — | — | — |
NCT00438984CT.gov Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Stage IV Melanoma | — | Completed | — | — | — |
NCT00328861CT.gov Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer | — | Completed | — | — | — |
NCT00314106CT.gov Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma | — | Completed | — | — | — |
NCT00303836CT.gov Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma | — | Terminated | — | — | — |
NCT00003552CT.gov Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Melanoma | — | Terminated | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Metastatic Melanoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fludarabine (this asset) | East Metropolitan Health Service, Australia | P3 | BB · 64 |
| Cediranib | M.D. Anderson Cancer Center | P2 | BBB |
| Dacarbazine | Shanghai Junshi Bioscience Co., Ltd. | P4 | BBB |
| Ifa | Craig L Slingluff, Jr | P2 | BB |
| Nivolumab | Bristol-Myers Squibb | P4 | BB |
| TIL | East Metropolitan Health Service, Australia | P2 | BB |
| Montanide Isa 51 | Ludwig Institute for Cancer Research | P2 | BB |
| Therapeutic Autologous Lymphocytes | Fred Hutchinson Cancer Center | P2 | BB |
| Ipilimumab | NYU Langone Health | P4 | BB |
+42 more in the Metastatic Melanoma cohort
Other indications for Fludarabine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult T-Cell Leukemia/Lymphoma | — | P2 | BBB · 76 |
| Acute Myeloid Leukemia With Abnormal Bone Marrow Eosinophils Inv(16)(P13q22) Or T(16;16)(P13;Q22) | — | P2 | BBB · 76 |
| Fanconi Anemia | — | P2/3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fludarabine in Metastatic Melanoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fludarabine-metastatic-melanoma
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