Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Amino Acids

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Carboplatin

Fluorouracil

Antibodies

Niraparib

Cetuximab

Methotrexate

Immunomodulating Agents

Durvalumab

Immunoglobulins

Palbociclib

Afatinib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Tyrosine Kinase Inhibitors

Tyrosine

Patients who are p16 negative and have an EGFR amplification/mutation or PTEN high or HER2 mutation/amplification will be randomized between afatinib or the standard of care (Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care).

Patients who are p16 negative and cetuximab naïve will be randomized between afatinib or the standard of care (Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care)

Patients who are p16 negative and have an amplification of CCND1 will be randomized between palbociclib or the standard of care (Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care)

Patients who are p16 negative and 'platinum sensitive' SCCHN will receive niraparib

Patients whith oropharyngeal cancer and which are p16 positive will receive niraparib

Patients who are anti-PD(L)1-naïeve or resistant (primary or secondary resistance) will receive IPH2201 antibody (monalizumab).

Patient who are PD(L)1 pretreated will be randomized between monalizumab + durvalumab or the standard of care (Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care)

Patient who are progressing prior PD(L)1 after having received at least 2 months of anti-PD(L)-1 will receive INCAGN01876.

Afatinib 40 mg given orally, once daily, 1 cycle is 28 days

Palbociclib 125 mg given orally, once daily, 1 cycle is 28 days (21 days on treatment, then 7 days off)

Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care

standard of care

protocol v2.0 and 2.1 : Monalizumab 10mg/kg given intravenously over 60 minutes, once every 14 days, 1 cycle is 14 days protocol v4.0 : Monalizumab 750mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days

IPH2201

Durvalumab 1500mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days

Niraparib 300 mg given orally, once daily, 1 cycle is 28 days

INCAGN01876 300 mg given intravenously over 30 minutes, once every 14 days, 1 cycle is 28 days

INCAGN01876

This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

Biomarker-based Study in R/M SCCHN

A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Progression Free Survival Rate (PFSR) at week 16 will be assessed as primary endpoint for all patients from cohorts 1, 2 and 3.

Objective response Rate (ORR) during the first 16 weeks of study treatment will be assessed as primary endpoint for all patients from cohort 4-8.

Objective Response Rate will be measured according to both RECIST 1.1 and iRECIST

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, for adverse event reporting.

European Organisation for Research and Treatment of Cancer - EORTC

Rare Diseases

Oral Squamous Cell Carcinoma

IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

The first 6 patients will receive IPH2201, IV, at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.

After the end of treatment with IPH2201, according to standard recommendations in the relevant country .

Standard Surgery

After the standard surgery, according to standard recommendations in the relevant country

Postsurgical Adjuvant Therapy

The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative patients with operable Squamous Cell Carcinoma of the Oral Cavity .

43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of IPH2201.

Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity

Open Label Single Arm Phase Ib-II Study of Pre-operative IPH2201 in Patients With Locally Advanced Resectable Squamous Cell Carcinoma of the Oral Cavity

Innate Pharma

Part 1: 1, 4 or 10mg/kg, IV, 1 hour duration on Day 1 every 2 weeks.

Part 2: Patients will receive single agent IPH2201 as above with the actual dose dependent on the outcome of Part 1

Hal Hirte

Anna Tinker

The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects it has on this type of cancer.

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy may cause this cancer to shrink for a time, better options are needed. In laboratory tests and animals, IPH2201 has been shown to have effects which result in shrinkage of tumours. IPH2201 has been studied in people with rheumatoid arthritis but it has not yet been studied in people with cancer and the investigators do not know if it can offer better results than standard treatment.

The standard or usual treatment for this disease could include surgery, chemotherapy or radiation.

A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies

To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin.

Correlative assays will be used to evaluate potential predictive markers of IPH2201 effects. Other potential prognostic or predictive molecular factors will be assesses in archival tumour tissue, CTCs and blood samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarker-based Study in R/M SCCHN	NCT03088059	Carcinoma, Squa...	Afatinib Palbociclib standard of car... IPH2201 Durvalumab Niraparib INCAGN01876	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity	NCT02331875	Squamous Cell C...	IPH2201 Standard Surger... Postsurgical Ad...	18 Years -	Innate Pharma
A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies	NCT02459301	Gynecologic Can...	IPH2201	18 Years -	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for iph2201

Every month we try and update this database with for iph2201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iph2201

Every month we try and update this database with for iph2201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iph2201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.