• Open cohorts: NTRK fusions (all tumor types) and ROS1 fusions (all tumors except NSCLC)
• Entrectinib PO 600 mg daily

• HCC
• HR+ Breast cancer
• TNBC
• Cutaneous squamous cell carcinoma
• Basal cell carcinoma
• CRC

 TVEC intrahepatic Q3W - Pembrolizumab Q3W IV 

• COHORT J: squamous cervix CPI naïve Q3W schedule
• COHORT N: squamous cervix CPI naïve QW/Q2W schedule 

• CAR-T cells will be administered with the first 3 cycles of FOLFOX. 
• Hospitalization of 4 days after CAR-T administration required

• Exclusion: NSCLC with EGFR mutation
• Afatinib 40mg/day with increase to 50 mg.

• Can have had standard or experimental treatment (excl. IL-2 compounds).
• Previous treatment with cetuximab is allowed.

AMG404: A Phase 1 study with AMG 404 (a PD-1 antibody) in patients with advanced solid tumors

• Melanoma
• SCLC
• NSCLC PD-L1 +
• HNSCC PD-L1 +
• Urothelial PD-L1 +
• Gastric/GEJ adone PD-L1 +
• Esophageal, squamous, PD-L1 +
• Cervical PD-L1 +
• HCC
• Merkel Cell Carcinoma
• SCC of the skin
• RCC, clear cell
• Undifferentiated pleiomorphic/malignant fibrous histiocytoma
• Poorly differentiated and/or dedifferentiated liposarcoma
• Alveolar Soft Tissue Sarcoma
• Angiosarcoma
• Thymic carcinoma
• Nasopharyngeal carcinoma, EBV positive
• Mesothelioma
• MSI-H or MMR-deficient tumors

• AMG 404 IV Q4W

• Archival tissue <1y old or fresh biopsy

CVPM087A2101: Phase Ib study of gevokizumab in combination with standard of care anti-cancer therapies in patients with metastatic colorectal cancer, gastroesophageal cancer and renal cell carcinoma

• 1L: 2 weeks gevokizumab monotherapy followed by gevokizumab + mFOLFOX6 + bevacizumab
• 2L: 2 weeks gevokizumab monotherapy followed by gevokizumab + FOLFIRI + bevacizumab
• CRP ≥ 10mg/L 

MS200647-0024: Phase Ib/II study of M7824 in combination with chemotherapy in participants with stage IV NSCLC

• Cohort A: 1L non-squamous NSCLC: Cisplatinum/Carboplatinum + Pemetrexed + M7824 Q3W
• Cohort B: 1L squamous or non-squamous NSCLC: Carboplatinum + nab-paclitaxel/paclitaxel + M7824 Q3W
• Cohort D: 2L squamous or non-squamous NSCLC: Docetaxel + M7824 Q3W --> Closed

MiMe-A: Multiorgan Metabolic imaging response assessment of Abemaciclib

• Esophageal adenocarcinoma --> limited slots
• Esophageal squamous cell carcinoma --> limited slots
• Cholangiocarcinoma --> Closed
• Urothelial cancer
• Endometrial cancer --> Closed

D419NC00001 (Medimmune): A phase ½ of Durvalumab and Monalizumab in adult subjects with select advanced solid tumors

• RAS/BRAF WT MSS
• No prior anti-EGFR therapy 
• Randomization 
  - cohort 2A: monalizumab Q2W + Durvalumab Q4W + Cetuximab Q2W
  - cohort 2B: monalizumab Q2W + Cetuximab Q2W 

AMG510: Phase 1/2 open label study with AMG510 monotherapy in subjects with advanced solid tumors with KRAS p.G12C mutation

• KRAS p.G12C mutation (central confirmation)
• CRC: progression after 5-FU, oxaliplatin and irinotecan --> Closed
• NSCLC: progression after anti-PD1/anti-PDL1 AND/OR platinum-based combination therapy AND targeted therapy. Not more than 3 prior lines of therapy. --> Closed
• Solid: progression after 1st line or ineligible for 1st line treatment --> Open

Open

NCT03600883

CV202-103: A Phase 1b/2 study of BMS-813160 in combination with chemotherapy or Nivolumab in patients with advanced solid tumors

• CRC: previous treated with one line of oxaliplatin-based systemic therapy in metastatic setting or progression on or within 6 months of adjuvant oxaliplatin based chemotherapy
• Pancreas: adenocarcinoma previously untreated or recurring systemically after surgery or >6 months post adjuvant therapy. Local recurrence alone not allowed.
• Able to swallow tablets
• Mandatory pre- and on-treatment biopsies

NCT03184870

BP41054: A Phase IB Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant Targeting Fibroblast Activation Protein-Α, In Combination With Pembrolizumab (Anti-Pd-1), In Participants With Advanced And/Or Metastatic Melanoma 

• Cutaneous unresectable stage III or stage IV melanoma. 
• Prior adjuvant anti-PD(L)1 or anti-CTLA-4 is permitted if relapse occurred during or < 6 months after completion.

NCT03875079

RAGNAR: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and Selected FGFR Gene Alterations

• FGFR mutations and FGFR fusions (NO amplifications!)
• Central testing allowed for:
•      Glioblastoma
•      Gliomas
•      SCCHN
•      Sarcoma
•      Cholangio
•      Endometrial
•      Cervix
•      Ovarian
•      NSCLC
•      RCC
•      Esophageal
•      Gastric
•      Breast: only HR+
•      HCC
•      Pancreatic
• Oral medication

NCT04083976

KISIMA-01: Phase Ib Study to evaluate the safety, tolerability and anti-tumor activity of ATP128, with or without BI 754091 in patients with stage IV CRC

• Ongoing PR or SD after completion of 1st line SOC therapy (min. 6 months) 
• 1 liver lesion amenable to repeated biopsy
• ATP128: chimeric recombinant protein vaccine
• BI754091: anti-PD1

NCT04046445

BLU-667: A Phase 1/2 study of the highly-selective RET inhibitor, BLU-667, in patients with thyroid cancer, NSCLC and other advanced solid tumors

• NSCLC: RET fusion
• Other solid tumors: RET fusion

• NSCLC: no prior platinum-based therapy
• Other solid tumors: previously treated with SOC therapy

• Oral medication 

NCT03037385

MIV-818: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients with Liver Cancer Manifestations

• Oral medication 
• Mandatory on-treatment liver biopsy 
• Child-Pugh A score 

NCT03781934

MCLA-145-CL01: A Phase 1, Open-label, Dose-escalation study of MCLA-145 in participants with advanced or metastatic malignancies 

• Dual CD137 + Anti-PD-L1 antibody 
• Prior anti-PD-1 is allowed (max 1 line)
• Mandatory pre- and on-treatment biopsy
• Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma

NCT03922204

SYD985.004:A Phase 1 study with the antibody-drug conjugate SYD985 in combination with Niraparib in patients with HER2-expressing locally advanced or metastatic solid tumors 

All solid tumors 

• SYD985 IV Q3W + Niraparib oral 
• HER2 tumor status at least 1+ assessed by IHC

NCT04235101

GO40987: A phase I, multicenter, open-label, preoperative, short-term window study of GDC-9545 in postmenopausal women with Stage I-III operable, estrogen receptor-positive breast cancer.

Breast

• ER+/Her2-negative unilateral breast cancer eligible for primary surgery
• Primary tumor >= 1.5 cm
• Postmenopausal women 
• Oral medication QD for 15d prior to surgery 

NCT03916744

INCB86550-102: A Phase 1 study with INCB086550 in patients with advanced solid tumors

• MSI-H/d MMR tumors
• Cutaneaous squamous cell carcinoma
• HCC
• PDL-1 positive esophageal squamous cell carcinoma
• Merkel cell carcinoma
• SCLC
• PDL-1 positive mesothelioma
• Any PDL-1 amplified tumor (9p24.1)
• Nasopharyngeal carcinoma
• Cyclin-dependent kinase 12 mutated tumors (loss of function, not amplification)
• Basal cell carcinoma (unresectable or metastatic)
• RCC with sarcomatoid features
• Clear cell ovarian or endometrial carcinoma
• DNA polymerase epsilon mutated tumors (P286R and V411L)

Other tumor types with approval of Medical Monitor

• Progressed after SOC or intolerant/ineligible for SOC
• No limit to number of prior treatment regims 

• Oral anti-PDL-1
• Mandatory screening + on treatment biopsy 

NCT03762447

Full molecular testing by RNA/DNA next generation sequencing to detect RNA/DNA alterations (including NRG1 fusions) 

• Whole genome sequencing of RNA/DNA (200 genes) 
• ≤ 60 years old at time of diagnosis
• KRAS mutated NOT eligible 

• Stage III
• max. 12 months on adjuvant HT
• ARM A: Ribociclib 400 mg + Letrozole (+/- Goserelin)
• ARM B: Letrozole (+/- Goserelin)

• Molecular study, no study treatment
• Blood samples every 6 months and at progression
• Biopsy after first or second progression and prior to next line of therapy

• No prior therapy in advanced setting
• Measurable disease per RECIST 1.1
• Arm 1: Ribociclib 400 mg + NSAI
• Arm 2: Ribociclib 600 mg + NSAI

• Recurrence/PD on or within 12m of end of adjuvant AI or PD while on AI for aBC/mBC.
• max. 2 prior ET for aBC/mBC
• max. 1 prior chemotherapy for aBC/mBC
• No prior Fulvestrant, SERDs, AKT, PI3K, and/or mTOR inhibitors
• prior CDK4/6 inhibitors allowed (max. 50% of target)
• Measurable disease per RECIST 1.1 or lytic bone only disease
• FFPE tumour sample available

• Min. 2 prior lines of chemotherapy in advanced/m+ setting
• Prior AC and Taxane
• Arm 1: Balixafortide (CXCR4 therapy)+ Eribulin
• Arm 2: Eribulin

• 1L chemo
• Cohort 1: TNBC (nivolumab/pembroluzimab/atezoluzimab + tesetaxel)
• Cohort 2: >= 65 years HR+ (tesetaxel)
• Tesetaxel = oral taxane therapy
• Archival tumor tissue available

• unilateral, (T1cN1; T2N1; T3N0) or locally advanced non inflammatory (T3N1; T4; any T and N2-3) or inflammatory (T4d any N)
• mandatory biopsy before Cycle 2
• baseline LVEF > 55%
• ARM A: neo-adj. chemotherapy + trastuzumab + pertuzumab; adjuvant trastuzumab + pertuzumab
• ARM B: neo-adj. chemotherapy + trastuzumab + pertuzumab + atezolizumab; adjuvant trastuzumab + pertuzumab + atezolizumab

• new diagnosis of FIGO IB-IVB or central recurrent invasive
• amenable for biopsy
• Ca/VitD supplements +/- denosumab 

EORTC 62113-55115: A phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Undifferentiated Uterine Sarcoma (HGUS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment

• locally advanced HGUS (FIGO III or IV) or residual disease after primary surgery or metastatic HGUS with relapse after local treatment
• ARM A: doxorubicin +/- ifosfamide with Carbozantinib
• ARM B: doxorubicin +/- ifosfamide with placebo

FUCHSIA: An open-label, single arm, prospective, multi-center, tandem two stage designed, phase II study to evaluate the efficacy of Fulvestrant in women with recurrent/metastatic estrogen receptor positive gynecological malignancies

• Recurrent or metastatic low grade uterine sarcomas, low grade endometrial carcinomas, sex cord tumors and low grade serous ovarian cancer
• Estrogen-receptor (ER) positive
• Hormonal therapy must have lasted for at least 3 months
• Fulvestrant treatment 

GCT1015-05/ENGOT-cx8: A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer

• Squamous, adenosquamous or adenocarcinoma
• Arm D (1st line): Tisotumab vedotin + carboplatinum AUC 5 (Q3W)
• Arm E (1st line): Tisotumab vedotin + pembrolizumab (Q3W)
• Arm G (2-3rd line): Tisotumab vedotin monotherapy (QW) 

NCT03786081

• Aspirin versus placebo
• Ro resection
• >45year
• stage II-III

SPOTLIGHT: A Double-Blind, Randomized, efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6

• Claudin 18.2-Positive on central lab
• HER2-Negative
• Locally Advanced Unresectable or Metastatic Adenocarcinoma

CAIRO 5: Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases

• Available KRAS/BRAF status mutation prior randomisation
• RAS WT: Folfox/folfiri + beva versus pani 
• RAS MUTANT: Folfox/folfiri versus folfoxiri + beva Liver expert panel will evaluate resectability status

TOPGEAR: Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

• Randomisation between preoperative chemo alone versus chemoradiation
• Chemo: ECF or ECX or EOX or FLOT
• Pre-op CRT: 5FU or capecitabine 

DZB-CS-301: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma

Intrahepatic CholangioCA

• Pre-screening on FGFR2 gene fusions or FGFR2 gene mutations or amplifications who received at least one prior regimen of systemic therapy

BGB-A317-306: Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment

Esophageal squamous cell carcinoma

• Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
• A treatment-free interval of at least 6 months after definitive treatment
• Exclusion: unintentional weight loss >5%, uncontrolled diabetes
• Arm A : Tislelizumab + chemo doublet. Chemo doublet: platinum and 5FU or platinum and paclitaxel
• Arm B: placebo + chemo doublet. Chemo doublet: platinum and 5FU or platinum and paclitaxel

TIGeR-PaC: Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy. 

Unresectable Locally Advanced Pancreatic Cancer

• Histologically or Cytopathology confirmed pancreatic adenocarcinoma
• Anatomy suitable for IA delivery of gemcitabine to the intended tumor site
• Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria
• initial diagnosis within 6 weeks of consent

• Historical or fresh biopsy required 
• ARM A treatment naïve triptorelin + bicalutamide or standar chemotherapy
• ARM B pretreated: triptorelin + bicalutamide
• Cross-over from Arm A SOC to Arm B possible

SCCHN: 

• oral cavity 
• oropharynx
• hypopharynx
• larynx 

• Fresh tumor core biospy, centrally assessed
• Cohort I2: Pretreated with prior PD(L)1
• Cohort B1: p16 negative and EGFR amplification/mutation or PTEN high or HER2 amplification/mutation
• Cohort B2: p16 negative and cetuximab naïve
• Cohort B3: p16 negative and CCND1 amplification
• Cohort B4: p16 negative and ‘platinum-sensitive’
• Cohort B5: p16 positive oropharyngeal cancer
• Cohort B6: FGFR1/2/3 mRNA overexpression
• Cohort I2: monalizumab + durvalumab vs. physician's choice
• Cohort B1 + B2: afatinib vs. physician's choice
• Cohort B3: palbociclib vs. physician's choice
• Cohort B4 + B5: Niraparib
• Cohort B6: rogaratinib

SCCHN Oropharynx HPV16+

• 1st line: tumors express PD-L1
• 2nd line: progression on or after platinum
• fresh biopsy, if possible
• no prior anti-PD(L)1

Thyroid (papillary or follicular)

• Up to two prior VEGFR-targeting TKI agents are allowed
• Previously treated with or deemed ineligible for Iodine-131
• QTcF < 500 ms

SCCHN 

• oral cavity
• pharynx
• larynx
• sinonasal
• nasopharyngeal
• unknown primary

HN9: Randomized Phase II study of Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy followed by Adjuvant Durvalumab vs Durvalumab + Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer

SCCHN Oropharynx p16+

• No induction chemotherapy allowed
• Intermediate risk:
• - T1-2 N1 (smoking ≥ 10 pack years) 
• - T3 N0-N1 (smoking ≥ 10 pack years)
• - T1-3 N2 (any smoking hx) 
• - Arm A: Cisplatin + RT
• - Arm B: Durvalumab + RT + adjuvant Durvalumab
• - Arm C: Durvalumab + RT + adjuvant Durvalumab-Tremelimumab --> closed

• Topotecan and Cyclophosphamide (TC)
• High dose Ifosfamide (IFOS)

• Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
• No Prior radiation or chemotherapy
• Total or subtotal resection
• No corticosteroid treatment ≤ 1 week before
• WT1 mRNA-loaded DC vaccination + CRT (temozolomide)

• Complete resection done
• Commence radiotherapy between within 12 weeks of surgery

• ≥ 2 bone metastases
• Ongoing androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy
• Prior docetaxel is permitted under the following conditions: started within 2 months of ADT initiation, given for a maximum of 6 cycles and progression after 6 months of the last dose of docetaxel.
• ARM A: Enzalutamide
• ARM B: Ra223 + Enzalutamide

• No previous exposure to cabozantinib prior to inclusion 

• T2, T3 or T4a, Nx, N0, N1 or N2, M0
• Cisplatin eligible: R1:1 MVAC+Avelumab or Cis-Gem+Avelumab
• Cisplatin ineligible: R1:1 Paclitaxel-Gem+Avelumab or Avelumab

• Cutaneous melanoma
• Metastases solely confined within the SN
• CLND or serial nodal observation according to patient decision

• Primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
• Retrospective and prospective

• Resectable stage IIA (≥ 4cm) to IIIB (T3N2)
• Tissue to be submitted before randomization 

• all subtyes. 
• cT1-3 N0-2 M0.
• 1:1 randomisation to P/D followed by adjuvant 3 cycles platinum-pemetrexed versus neoadjuvant 3 cycles platinum-pemetrexed followed by P/D.

• early referal (at least during second cycle chemo) required.
• all sybtypes.
• 1:1 radomisation MesoPher plus BSC versus BSC alone.
• no known allergy to shellfish.
• no history of auto-immune diseases.

• all subtypes.
• no progression after 4-6 cycles platinum-based chemotherapy.
• randomisation within 60 days from last dose of chemotherapy.              
• nintedanib or placebo oral twice daily

• at least one previous line of platinum-based chemotherapy.
• no history of myasthenia or auto-immune disease.
• nivolumab q2w.

• EGFR activating mutation

• MET amplification in TBx, (central or local FISH), or in LBx (central)
• Prior objective clinical benefit to previous osimertinib 
• Radiologic disease progression to previous osimertinib
• Tepotinib + osimertinib or Tepotinib monotherapy

• Arm A: Pralsetinib PO

• Arm B: Carboplatin or cisplatin/pemetrexed; Pembrolizumab/carboplatin or cisplatin/pemetrexed; Carboplatin or cisplatin/gemcitabine 

• Tissue to be submitted (archived/fresh)

• Crossover possible after central confirmed PD

• CEACAM5 >=2+ (centrally assessed)
• prior platinum and immune checkpoint inhibitor
• no previous corneal disorder
• contact lenses are not permitted

• Cohort A: 1L non-squamous NSCLC: Cisplatinum/Carboplatinum + Pemetrexed + M7824 Q3W
• Cohort C: 1L squamous or non-squamous NSCLC: Cisplatinum/Carboplatinum + Gemcitabine + M7824 Q3W --> Closed
• Cohort D: 2L squamous or non-squamous NSCLC: Docetaxel + M7824 Q3W --> Closed

• Only cohort for NTRK fusions still open
• Entrectinib PO 600 mg daily

• Cohort 1: NSCLC exon 14 mutated --> Closed

• Cohort 2: PD after anti-EGFR with an aquired MET amplification

• Not more than 1 line containing PD-1 or PDL-1 targeting agent

• ABBV-181 IV Q4W + Venetoclax PO daily 

NCT03000257

NSCLC

stage IIIb-IV

• KRAS p.G12C mutation centrally confirmed

• Prior platinum-based doublet and checkpoint inhibitor for advanced or metastatic disease, either as one line or as individual lines

NCT04303780

All solid tumors 

• Dual CD137 + Anti-PD-L1 antibody
• Prior anti-PD-1 is allowed (max 1 line) 
• Mandatory pre- and on-treatment biopsy 
• Specific inclusion criteria for TNBC, melanoma, HNSCC and urothelial carcinoma

NCT03922204