Adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.CHECKMATE-76K
Skin Cancers
Cutaneous Melanoma
-
CHECKMATE-76K
A
PRELIMINARY SCORE
RFS
ADJUSTMENTS
SCORE
F1
A
Encorafenib
Binimetinib
Single arm
Encorafenib plus binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation - previously treatedPHAROS
Thoracic Malignancies
Non-small-cell Lung Cancer
BRAF V600E mutation
PHAROS
3
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
3
Encorafenib
Binimetinib
Single arm
Encorafenib plus binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation - treatment naïvePHAROS
Thoracic Malignancies
Non-small-cell Lung Cancer
BRAF V600E mutation
PHAROS
3
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
3
Docetaxel
Oxaliplatin–S-1 + surgery + adjuvant S-1
Surgery + adjuvant S-1
Peri-operative therapy for the treatment of resectable advanced gastric cancerPRODIGY
Gastrointestinal Cancers
Gastric Cancer
-
PRODIGY
A
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F1
A
Cisplatin/S-1
-
5-FU + cisplatin
First-line therapy for advanced gastric cancerFLAGS
Gastrointestinal Cancers
Gastric Cancer
-
FLAGS
NEB
PRELIMINARY SCORE
NEB
ADJUSTMENTS
SCORE
F2a
NEB
Toripalimab
-
Single arm
Toripalimab as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.POLARIS-02
Head and neck cancer
Nasopharyngeal carcinoma
-
POLARIS-02
3
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
3
Fruquintinib
Best supportive care
Placebo + best supportive care
Fruquintinib for adult patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy.FRESCO
Gastrointestinal Cancers
Colorectal Cancer
-
FRESCO
3
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
3
Fruquintinib
Best supportive care
Placebo + best supportive care
Fruquintinib for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, if RAS wild-type and medically appropriate, an anti-EGFR therapy, and at least one of trifluridine/tipiracil or regorafenib.FRESCO -2
Gastrointestinal Cancers
Colorectal Cancer
-
FRESCO -2
3
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
3
Tucatinib
Trastuzumab
Single arm
Treatment of patients with RAS wild-type, HER2-positive unresectable or mCRC that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based ChT MOUNTAINEER
Gastrointestinal Cancers
Colorectal Cancer
-
MOUNTAINEER
3
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
3
Pembrolizumab
Fluoropyrimidine and platinum-containing ChT
Placebo + fluoropyrimidine and platinum-containing ChT
Pembrolizumab with fluoropyrimidine and platinum-containing ChT for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.KEYNOTE-859
Gastrointestinal Cancers
Gastric or gastroesophageal junction adenocarcinoma
HER2-
KEYNOTE-859
1
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
1
Capivasertib
Fulvestrant
Placebo + fulvestrant
Capivasertib with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapyCAPItello-291
Breast Cancer
Breast Cancer
PIK3CA/AKT1/PTEN- ; HR+ ; HER2-
CAPItello-291
3
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
3
Pembrolizumab
Gemcitabine and cisplatin
Placebo + gemcitabine and cisplatin
EMA: Pembrolizumab in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults. FDA: Pembrolizumab to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.KEYNOTE-966
Gastrointestinal Cancers
Biliary tract cancer
-
KEYNOTE-966
1
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
1
Enfortumab vedotin
Pembrolizumab
Single arm
For patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.EV-103/KEYNOTE-869
Genitourinary Cancers
Urothelial Carcinoma
-
EV-103/KEYNOTE-869
2
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
2
Atezolizumab
-
ChT (vinflunine, paclitaxel or docetaxel)
Treatment of patients with locally advanced or metastatic UC after prior platinum-containing ChT IMvigor211
Genitourinary Cancers
Urothelial Carcinoma
-
IMvigor211
NEB
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
NEB
Erdafitinib
-
ChT (docetaxel or vinflunine)
FDA: For adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy./ EMA: Erdafitinib as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment settingTHOR/BLC3001 cohort 1
Genitourinary Cancers
Urothelial Carcinoma
FGFR3
THOR/BLC3001 cohort 1
4
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
4
Sacituzumab govitecan
-
Single arm
Treatment of patients with locally advanced or metastatic UC who have previously received a platinum-containing ChT and either PD-1 or PD-L1 inhibitor TROPHY-U-01
Genitourinary Cancers
Urothelial Carcinoma
-
TROPHY-U-01
2
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
2
Enzalutamide
Leuprolide
Placebo + Leuprolide
As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy. Combination group EMBARK
Genitourinary Cancers
Prostate cancer
PSA doubling time ≤ 9 months
EMBARK
3
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
3
Durvalumab
-
Sorafenib
Durvalumab as monotherapy indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC)HIMALAYA
Gastrointestinal Cancers
Hepatobiliary Cancers - Hepatocellular Carcinoma
-
HIMALAYA
4
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2c
4
Nirogacestat
-
Placebo
Nirogacestat for adult patients with progressing desmoid tumours who require systemic treatment.DeFi
Non-cancerous soft-tissue tumour
Desmoid (fibrous tissue)
-
DeFi
4
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
4
Nivolumab
Cisplatin-based ChT (Gemcitabine+Cisplatin)
Standard of care chemotherapy (Gemcitabine+Cisplatin)
Nivolumab in combination with cisplatin-based chemotherapy in the first-line setting for the treatment of patients with unresectable or metastatic urothelial carcinomaCHECKMATE-901
Genitourinary Cancers
Urothelial Carcinoma
-
CHECKMATE-901
2
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
2
Eflornithine
-
Popensity score matched external control from ANBL0032. Matched cohort 3:1
Eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. HRNB postimmunotherapy maintenanceStudy 3b, NMTRC003B - ANBL0032
Brain Tumours
Neuroblastoma
-
Study 3b, NMTRC003B - ANBL0032
A
PRELIMINARY SCORE
EFS
ADJUSTMENTS
SCORE
F1
A
Bevacizumab
FOLFOX4 (oxaliplatin, folinic acid, 5-fluorouracil) or CAPOX (Capecitabine)
Placebo for Bevacizumab
Treatment of patients with metastatic carcinoma of the colon or rectum NO16966
Gastrointestinal Cancers
Colorectal Cancer
-
NO16966
1
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
1
Tislelizumab
Pemetrexed + platinum‑containing ChT
Pemetrexed + platinum‑containing ChT
Tisleizumab in combination with pemetrexed and platinum‑containing ChT is indicated for the first-line treatment of adult patients with NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLCRATIONALE 304
Thoracic Malignancies
Non-small-cell Lung Cancer
PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations
RATIONALE 304
4
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
4
Tislelizumab
-
Docetaxel
Tislelizumab as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.RATIONALE 303
Thoracic Malignancies
Non-small-cell Lung Cancer
EGFR and ALK positive
RATIONALE 303
5
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
5
Osimertinib
Osimertinib ± Platinum Plus Pemetrexed ChT (Carboplatin, Cisplatin)
Osimertinib
FDA/EMA: Osimertinib with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. FLAURA 2
Thoracic Malignancies
Non-small-cell Lung Cancer
EGFR exon 19 deletions or exon 21 L858R mutations
FLAURA 2
3
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
3
Lifileucel
-
Single arm
Treatment for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.LN-144
Skin Cancers
Melanoma
-
LN-144
2
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
2
Irinotecan liposome
Oxaliplatin, fluorouracil, and leucovorin
Nab-paclitaxel + gemcitabine
Irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.NAPOLI 3
Gastrointestinal Cancers
Pancreatic cancer
-
NAPOLI 3
2
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
2
Dab/Tram (dabrafenib and trametinib)
-
Single arm
Adult and paediatric patients ≥1 year of age with unresectable or metastatic solid tumours with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options ROAR, NCI-MATCH (subprotocol H)
Tumour agnostic
-
BRAF V600E mutated rare cancers
ROAR, NCI-MATCH (subprotocol H)
3
PRELIMINARY SCORE
ORR
ADJUSTMENTS
SCORE
F3
3
Enfortumab
Pembrolizumab
Platinum-based ChT
FDA: Enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer. EMA: Pembrolizumab, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.EV-302/KN-A39
Genitourinary Cancers
Urothelial Carcinoma
-
EV-302/KN-A39
4
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
4
Amivantamab
Carboplatin and Pemetrexed
Carboplatin and Pemetrexed
FDA: Amivantamab with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. EMA: Amivantamab in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutationsPAPILLON
Thoracic Malignancies
Non-small-cell Lung Cancer
EGFR+ exon 20 insertion mutations
PAPILLON
3
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
3
Watchlist
Tested Agent(s)
Combined Agent(s)
Control Arm
Therapeutic Indication
Tumour Type
Tumour Sub-type
Tumour Sub-group
Trial Name
Ref.
Score
Scorecard
Scorecard
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