Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Mouth and Tooth Diseases

Heart and Blood Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Stomach Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Pancreatic Neoplasms

Lymphoma

Adenocarcinoma

Cholangiocarcinoma

Leukemia

Leukemia, Lymphoid

Melanoma

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Mouth Neoplasms

Kidney Neoplasms

Waldenstrom Macroglobulinemia

Lymphoma, Non-Hodgkin

Fallopian Tube Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Hematologic Diseases

Fallopian Tube Diseases

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Liver Diseases

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Pancreatic Cancer

Lymphosarcoma

Bile Duct Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Fallopian Tube Cancer

Oral Cancer

Laryngeal Cancer

Indolent B Cell Lymphoma

Lip and Oral Cavity Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Gastrointestinal Agents

Amino Acids

Antibodies

Paclitaxel

Gemcitabine

Pembrolizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Liver Extracts

Pancrelipase

Pancreatin

Flt3 ligand protein

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tyrosine

Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.

Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.

Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.

Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.

CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.

CDX-1140

CDX-301 will be injected once a day for five days before Cycles 1 and 2.

CDX-301

pembrolizumab will be administered every 3 weeks.

pembrolizumab

Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.

Chemotherapy

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.

All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies

The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

The percentage of patients who achieved a confirmed complete response or partial response by evaluation criteria in solid tumors for immune-based therapeutics (iRECIST; for solid tumor patients) and the lymphoma response to immunomodulatory therapy criteria (LYRIC; for lymphoma patients).

The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months

The interval from which measurement criteria are first met for CR or PR until the first date that progressive disease is objectively documented

The time from start of study drug to time of progression or death, whichever occurs first

The time from start of study drug to death

Serum samples will be obtained for assessment of human anti-CDX-1140 and anti-CDX-301 antibodies

CDX-1140 and CDX-301 concentrations will be measured

Merck Sharp & Dohme LLC

Celldex Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	NCT03329950	Melanoma Non-small Cell ... Breast Cancer Gastric Cancer Renal Cell Carc... Ovarian Cancer Cholangiocarcin... Bladder Urothel... Pancreatic Aden... Colorectal Canc... Esophageal Canc... Hepatic Cancer Head and Neck C... Primary Periton... Fallopian Tube ... Other Solid Tum... Diffuse Large B... Mantle Cell Lym... Indolent B-cell... Non-Hodgkin Lym... Follicular Lymp... Lymphoplasmacyt... Waldenstrom's D... Marginal Zone L... Mucosa Associat... Small Lymphocyt...	CDX-1140 CDX-301 pembrolizumab Chemotherapy	18 Years -	Celldex Therapeutics

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