Fianlimab History and Updates

117 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
117
Trial Milestones
0
Pivotal Publications
Fianlimab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2017201820192020202120222023202420252026202720282029203020312032203320342035Trial: NCT07346196 2027-02-07 → 2031-08-22 (primary completion)Trial: NCT07179315 2026-12-01 → 2029-11-30 (primary completion)Trial: NCT07511036 2026-09-01 → 2028-05-24 (primary completion)Trial: NCT07567469 2026-08-31 → 2032-08-27 (primary completion)Trial: NCT07281768 2026-07-31 → 2030-07-31 (primary completion)Trial: NCT07527325 2026-07-01 → 2029-02-01 (primary completion)Trial: NCT07224022 2026-07-01 → 2028-08-31 (primary completion)Trial: NCT07365839 2026-07-01 → 2035-02-28 (primary completion)Trial: NCT07414992 2026-05-31 → 2028-03-31 (primary completion)Trial: NCT07188896 2026-04-29 → 2029-11-30 (primary completion)Trial: NCT06769698 2026-04-14 → 2028-06-04 (primary completion)Trial: NCT07234058 2026-02-28 → 2028-05-31 (primary completion)Trial: NCT07223541 2026-01-15 → 2029-08-31 (primary completion)Trial: NCT07223411 2025-11-19 → 2028-11-01 (primary completion)Trial: NCT06571708 2025-08-14 → 2028-12-31 (primary completion)Trial: NCT06865339 2025-08-07 → 2027-08-31 (primary completion)Trial: NCT07058012 2025-08-01 → 2029-04-17 (primary completion)Trial: NCT06887088 2025-05-29 → 2028-01-31 (primary completion)Trial: NCT06787612 2025-05-28 → 2028-10-30 (primary completion)Trial: NCT06918132 2025-04-29 → 2027-04-29 (primary completion)Trial: NCT06848088 2025-04-14 → 2029-10-10 (primary completion)Trial: NCT06699602 2025-02-11 → 2028-02-29 (primary completion)Trial: NCT06384820 2024-11-14 → 2026-06-08 (primary completion)Trial: NCT06190951 2024-09-18 → 2026-11-02 (primary completion)Trial: NCT06594991 2024-09-10 → 2027-09-30 (primary completion)Trial: NCT06246916 2024-09-09 → 2027-03-22 (primary completion)Trial: NCT06161441 2024-07-16 → 2026-04-20 (primary completion)Trial: NCT06205836 2024-06-13 → 2030-05-31 (primary completion)Trial: NCT05800015 2023-08-08 → 2030-01-16 (primary completion)Trial: NCT05929664 2023-07-05 → 2031-07-05 (primary completion)Trial: NCT05785767 2023-06-30 → 2030-03-11 (primary completion)Trial: NCT05608291 2023-01-16 → 2028-05-16 (primary completion)Trial: NCT05137054 2022-08-17 → 2028-04-11 (primary completion)Trial: NCT05352672 2022-07-14 → 2026-03-12 (primary completion)Trial: NCT04989946 2021-12-16 → 2026-12-31 (primary completion)Trial: NCT04590326 2020-12-08 → 2027-03-25 (primary completion)Trial: NCT03916627 2019-07-23 → 2025-03-31 (primary completion)Trial: NCT03233139 2017-06-21 → 2027-09-30 (primary completion)today (2026-06-11)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Fianlimab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2026

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07365839
Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07281768
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT07567469
A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07511036
PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06190951
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07179315
A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT04989946
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk P
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06246916
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT04590326
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab,
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03233139
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanc
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06887088
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05137054
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple M
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05608291
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Comi
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07511036
PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07234058
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07058012
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Pati
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06769698
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06787612
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Primary completion· ClinicalTrials.gov
Primary completion: NCT07223411
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Mela
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06571708
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07058012
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Pati
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07223541
Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06848088
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07188896
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07179315
A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment
Primary completion· ClinicalTrials.gov
Phase 2/Phase 3 primary completion: NCT05800015
A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treat
Primary completion· ClinicalTrials.gov
Phase 2/Phase 3 primary completion: NCT05785767
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06205836
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07281768
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05929664
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT07567469
A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06384820
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07414992
A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07188896
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06161441
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab a
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06161441
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab a
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06769698
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05352672
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated U
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07234058
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07223541
Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
2025
Trial started· ClinicalTrials.gov
Trial started: NCT07223411
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Mela
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06571708
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06865339
Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07058012
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Pati
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06887088
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06787612
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06918132
Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06848088
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06384820
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06190951
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06246916
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06161441
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab a
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06205836
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
2023
Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT05800015
A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treat
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05929664
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT05785767
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05608291
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Comi
2022
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05137054
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple M
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05352672
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated U
2021
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT04989946
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk P
2020
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT04590326
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab,
2019
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT03916627
Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
2017
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03233139
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanc

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.