Microsatellite instability-high (MSI-H) — biomarker · CancerIndex

Biomarker · MSI / MMR

Microsatellite instability-high (MSI-H)

Length instability of microsatellite loci detected by PCR or sequencing of tumor DNA, the genomic consequence of mismatch-repair deficiency; used as a tissue-agnostic predictive marker for immune checkpoint inhibitors and as a screening marker for Lynch syndrome.

CI-BIO-00000027MLH1 graph →MSH2 graph →MSH6 graph →PMS2 graph →NCIt C36493 Tumor-agnostic · 1 approval row

Also calledMSI-H · MSI-high · microsatellite instability · MSI

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (1)

Pembrolizumab US FDA · Sep 4, 2014 · matched on indication textRegulatory approved

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (4)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Gastric Carcinoma	2	1	1	—	0 / 2 / 0 / 0 / 0
Transitional Cell Carcinoma	2	2	—	—	0 / 0 / 2 / 0 / 0
Glioblastoma	1	1

Derived

Drugs with predictive evidence (4)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
NivolumabMonoclonal Antibody	2	2	—	B	3 / 0	Glioblastoma, Malignant Neoplasm
Anti-PD-1 Monoclonal Antibody MEDI0680	2	2	—	C	2 / 0	Transitional Cell Carcinoma
DurvalumabMonoclonal Antibody	2	2	—	C	2 / 0	Transitional Cell Carcinoma
OxaliplatinSmall Molecule	1	—	1	B	0 / 1	Gastric Carcinoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (5)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–5 of 5 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
MLH1 METHYLATION1
Oxaliplatin	Gastric CarcinomaALIAS	Predictive	B	Supports Resistance	2	accepted	EID1315 The methylation status of MLH1 was analyzed in a study of 53 paraffin-embedded gastric cancer samples. No association was found between methylation status and clinical factors. The study showed that M… (full text at CIViC) PMID 24748501 · Li et al., 2015 · Open in CIViC	civic
PMS2 K706FS*191
Nivolumab	GlioblastomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID1214 Two siblings (6 and 3.5 years) from nonconsanguineous parents were diagnosed with glioblastoma multiforme. Both tumors harbored TP53 mutations and lack of MGMT promoter hypermethylation as poor progno… (full text at CIViC) PMID 27001570 · Bouffet et al., 2016 · Open in CIViC	civic
MLH1 Loss + MSH2 LossMLH1 MSH21
Nivolumab	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID11677 In this NCI-MATCH trial, 42 patients with 19 different cancers, none of which were colorectal, harbouring MMR deficiency defined by MLH1 or MSH2 loss were treated with Nivolumab. The three most common… (full text at CIViC) PMID 31765263 · Azad et al., 2020 · Open in CIViC	civic
MSH2 Loss1
Anti-PD-1 Monoclonal Antibody MEDI0680 + DurvalumabCombination	Transitional Cell Carcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1877 Case report of a 45-year old woman of Japanese descent with recurrent urothelial carcinoma. The patient was identified to harbor mutations in MSH2 (A913fs2, E226, E580*) and in MSH6 (R361H) by panel… (full text at CIViC) PMID 26674132 · Castro et al., 2015 · Open in CIViC	civic
MSH6 LOSS1
Anti-PD-1 Monoclonal Antibody MEDI0680 + DurvalumabCombination	Transitional Cell Carcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1878 Case report of a 45-year old woman of Japanese descent with recurrent urothelial carcinoma. The patient was identified to harbor mutations in MSH2 (A913fs2, E226, E580*) and in MSH6 (R361H) by panel… (full text at CIViC) PMID 26674132 · Castro et al., 2015 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (160)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfdaRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Pembrolizumab	US FDA	Tumor-agnostic	for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. • Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. • Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. • in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. • in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. • for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. • Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 • Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. • Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. • 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

7 records matched on indication text only (drug not in the derived set). Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (50)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 26 recruiting · 5 active phase 3 · 173 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 50 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03899155	Pan Tumor Rollover Study	recruiting	Phase 2	1,500	Bristol-Myers SquibbINDUSTRY	38	Sep 23, 2026	clinicaltrials
NCT07405164	Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)	recruiting	Phase 3	450	Merck Sharp & Dohme LLCINDUSTRY	22	Sep 23, 2026	clinicaltrials
NCT03776487	Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer	active not recruiting	Phase 2	32	M.D. Anderson Cancer CenterOTHER	1	Sep 18, 2026	clinicaltrials
NCT05267626	Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer	recruiting	Phase 1 / Phase 2	159	Aulos Bioscience, Inc.INDUSTRY	2	Sep 18, 2026	clinicaltrials
NCT06816927	Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab(GIANT)	recruiting	Phase 2	92	Duke UniversityOTHER	2	Sep 17, 2026	clinicaltrials
NCT03847649	A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies	recruiting	Phase 2	60	Canadian Cancer Trials GroupNETWORK	1	Sep 15, 2026	clinicaltrials
NCT06730373	First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)	recruiting	Phase 2	110	Qilu Hospital of Shandong UniversityOTHER	1	Sep 15, 2026	clinicaltrials
NCT05502315	Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer(CANOPY)	active not recruiting	Phase 2	47	Rana McKay, MDOTHER	1	Sep 8, 2026	clinicaltrials
NCT07801027	A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)	not yet recruiting	Phase 4	150	Merck Sharp & Dohme LLCINDUSTRY	0	Sep 3, 2026	clinicaltrials
NCT07283939	Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays	recruiting	N/A	420	Alliance for Clinical Trials in OncologyOTHER	3	Sep 2, 2026	clinicaltrials
NCT05891171	Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers(ARC-25)	active not recruiting	Phase 1	40	Arcus Biosciences, Inc.INDUSTRY	3	Aug 31, 2026	clinicaltrials
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Aug 28, 2026	clinicaltrials
NCT04329494	PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer	recruiting	Phase 1	49	City of Hope Medical CenterOTHER	1	Aug 26, 2026	clinicaltrials
NCT07620574	Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study	enrolling by invitation	Phase 3	5,000	ExelixisINDUSTRY	1	Aug 18, 2026	clinicaltrials
NCT05919264	FOG-001 in Locally Advanced or Metastatic Solid Tumors	recruiting	Phase 1 / Phase 2	619	Parabilis Medicines, Inc.INDUSTRY	2	Aug 17, 2026	clinicaltrials
NCT05303532	Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab(ROSY-D)	enrolling by invitation	Phase 3	214	AstraZenecaINDUSTRY	31	Aug 11, 2026	clinicaltrials
NCT05663710	Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC	recruiting	Phase 1 / Phase 2	100	M.D. Anderson Cancer CenterOTHER	1	Jul 30, 2026	clinicaltrials
NCT06764771	A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors	recruiting	Phase 1	437	Bristol-Myers SquibbINDUSTRY	3	Jul 29, 2026	clinicaltrials
NCT07518043	A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors	recruiting	Phase 1	174	Shanghai Henlius BiotechINDUSTRY	1	Jul 27, 2026	clinicaltrials
NCT05802056	Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis	active not recruiting	Phase 1	15	Mayo ClinicOTHER	1	Jul 1, 2026	clinicaltrials
NCT06346197	Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas(CIME)	recruiting	Phase 3	132	Centre Leon BerardOTHER	1	Jun 25, 2026	clinicaltrials
NCT02834013	Nivolumab and Ipilimumab in Treating Patients With Rare Tumors	active not recruiting	Phase 2	798	National Cancer Institute (NCI)NIH	2	Jun 17, 2026	clinicaltrials
NCT04323046	Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults	active not recruiting	Phase 1	9	Sabine Mueller, MD, PhDOTHER	2	Jun 15, 2026	clinicaltrials
NCT05076760	MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors	recruiting	Phase 1	40	Memgen, Inc.INDUSTRY	1	Jun 11, 2026	clinicaltrials
NCT00492999	Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver	active not recruiting	Phase 2	64	Memorial Sloan Kettering Cancer CenterOTHER	1	Jun 3, 2026	clinicaltrials
NCT04003649	IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM	active not recruiting	Phase 1	20	City of Hope Medical CenterOTHER	1	May 14, 2026	clinicaltrials
NCT07432295	Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)	recruiting	Phase 2	180	I-Mab Biopharma US LimitedINDUSTRY	3	May 14, 2026	clinicaltrials
NCT03686124	ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors(ACTengine)	recruiting	Phase 1 / Phase 2	375	Immatics US, Inc.INDUSTRY	2	May 13, 2026	clinicaltrials
NCT06682728	Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence	recruiting	Phase 2	23	University of California, IrvineOTHER	1	Apr 30, 2026	clinicaltrials
NCT05257590	CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma	recruiting	Phase 2	95	TaiRx, Inc.INDUSTRY	1	Apr 13, 2026	clinicaltrials
NCT06362369	A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy	recruiting	Phase 1 / Phase 2	126	7 Hills Pharma, LLCINDUSTRY	1	Apr 13, 2026	clinicaltrials
NCT04336241	Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors	active not recruiting	Phase 1	36	Replimune, Inc.INDUSTRY	2	Feb 27, 2026	clinicaltrials
NCT04606316	Surgical Nivolumab And Ipilimumab For Recurrent GBM	active not recruiting	Phase 1	63	Patrick Wen, MDOTHER	1	Feb 17, 2026	clinicaltrials
NCT06208657	Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer	recruiting	Phase 1 / Phase 2	90	Australian & New Zealand Children's Haematology/Oncology GroupOTHER	2	Jan 28, 2026	clinicaltrials
NCT03743662	Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma	active not recruiting	Phase 2	39	Memorial Sloan Kettering Cancer CenterOTHER	1	Jan 7, 2026	clinicaltrials
NCT04495296	A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors	recruiting	Phase 1 / Phase 2	320	Suzhou Transcenta Therapeutics Co., Ltd.INDUSTRY	1	Dec 19, 2025	clinicaltrials
NCT04396821	A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors	active not recruiting	Phase 1 / Phase 2	150	Suzhou Transcenta Therapeutics Co., Ltd.INDUSTRY	1	Dec 17, 2025	clinicaltrials
NCT03718767	Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype	active not recruiting	Phase 2	62	National Cancer Institute (NCI)NIH	1	Nov 24, 2025	clinicaltrials
NCT03233152	A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma.(GlitIpNi)	active not recruiting	Phase 1 / Phase 2	110	Universitair Ziekenhuis BrusselOTHER	1	Nov 21, 2025	clinicaltrials
NCT04295863	Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers	recruiting	Phase 1	264	University of ChicagoOTHER	1	Oct 1, 2025	clinicaltrials
NCT05909618	Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases(14)	recruiting	Phase 2	33	Sheba Medical CenterOTHER_GOV	1	Jul 22, 2025	clinicaltrials
NCT04047706	Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma	active not recruiting	Phase 1	18	Northwestern UniversityOTHER	1	Jun 29, 2025	clinicaltrials
NCT06896110	Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma	enrolling by invitation	Phase 1	34	Andrew P. GrovesOTHER	1	Jun 26, 2025	clinicaltrials
NCT05970497	A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors	recruiting	Phase 1 / Phase 2	240	Krystal Biotech, Inc.INDUSTRY	1	May 18, 2025	clinicaltrials
NCT06028737	Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer(OCTASUR)	recruiting	Phase 2 / Phase 3	150	Ukrainian Society of Clinical OncologyOTHER	2	May 6, 2025	clinicaltrials
NCT03452579	Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM	active not recruiting	Phase 2	90	David PeereboomOTHER	1	Feb 28, 2025	clinicaltrials
NCT04195139	Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM(NUTMEG)	active not recruiting	Phase 2	103	University of SydneyOTHER	2	Dec 11, 2024	clinicaltrials
NCT04300244	Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma(NIPU)	active not recruiting	Phase 2	118	Åslaug HellandOTHER	5	Feb 29, 2024	clinicaltrials
NCT04392505	Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study(DART)	active not recruiting	Phase 2	100	Oslo University HospitalOTHER	4	Feb 29, 2024	clinicaltrials
NCT02925234	The Drug Rediscovery Protocol (DRUP Trial)(DRUP)	recruiting	Phase 2	1,550	The Netherlands Cancer InstituteOTHER	1	Jan 24, 2024	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Durvalumab

EU EMA

—

Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).  Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

approved

Sep 21, 2018

ema

Ipilimumab

EU EMA

—

Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).  Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

approved

Jul 13, 2011

ema

Nivolumab

EU EMA

—

Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle …

approved

Jun 19, 2015

ema

Approval rows flagged tumor-agnostic (1)

Associated cancers (4)

Drugs with predictive evidence (4)

Predictive evidence items (5)

Approvals mentioning the linked drugs (160)

Active trials (50)

Linked publications (6)