Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma

STATUS

Recruiting

Updated on 22 December 2020

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lymphomas

lymphoma

non-hodgkin's lymphoma

Summary

This is a multi-center Phase 1/2 open label trial of intratumoral G100 in patients with low grade NHL. Patients with NHL will be enrolled and receive G100 to an accessable tumor mass. Clinical response will be evaluated in the injected lesion and systemic (abscopal) responses will be evaluated in distal areas involved with tumor.

The study will be conducted in 5 parts.

In Part 1, Dose Escalation, 2 sequentially enrolled cohorts of patients will be treated at one of 2 dose levels of G100 using a standard escalation design. In this portion of the study, both follicular and marginal zone NHL will eligible.

In Part 2, 2 groups of patients with follicular NHL may be examined. One group will be randomly assigned to receive either single agent G100 intratumorally at the maximum safe dose determined in Part 1 following local radiation or will receive the same treatment regimen sequentially administered with pembrolizumab. A second treatment group may be explored if the safety profile in Part 1 is acceptable. In this optional group, patients with injectable tumors of 4 cm or greater would be enrolled and treated with a higher dose of G100.

In Part 3, expansion of a higher dose (20µg of G100) in patients with follicular NHL will be enrolled to receive local radiation therapy and intratumoral G100 (no tumor size requirement in this arm).

In Part 4, Dose Escalation and Expansion, a dose of 20µg of G100 will be examined as a treatment of 1 or more tumor lesions (up to 4) with pembrolizumab in order to establish safety and examine clinical and biomarker responses in patients receiving increasing total systemic doses of G100.

In Part 5, Dose Escalation, increasing doses of G100 (in combination with rituximab) in a single tumor lesion will be examined. Once the highest dose has been established as safe, a Patient Expansion group may be treated.

The primary goal of this study is to determine the safety and tolerability of different doses of G100 when administered by intratumoral injection. The development of anti-tumor immune responses and preliminary evidence of clinical responses in local and distal tumor sites will also be examined.

Description

See CT.gov: www.clinicaltrials.gov/ct2/show/NCT02501473

Details

Condition	Lymphoma, Non-Hodgkin's Lymphoma, Follicular Lymphoma Immune System Diseases Follicular NHL Follicular Non-Hodgkin's Lymphoma Low-grade Lymphoma
Clinical Study Identifier	TX218233
Last Modified on	22 December 2020

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Follicular low-grade NHL (grades 1, 2, 3A)
	In Parts 1-3, either treatment naive or relapsed or refractory following at least one prior treatment. For France, patients with either relapsed or refractory only. In Part 1 Dose Escalation only, in addition to follicular NHL, marginal zone B cell lymphomas: either treatment naive or relapsed or refractory following at least one prior treatment
	In Part 4, enrollment is limited to relapsed or refractory follicular NHL patients who have received at least 3 prior systemic treatments, one of which was or included an anti-CD20 antibody
	In Part 5, enrollment will include relapsed or refractory CD20+ follicular NHL following at least one but not more than 2 prior treatments
	Tumor mass(es) accessible for intratumoral injection. Imaging assisted injections are allowed
	For Parts 4 and 5, Measurable tumor mass(es) accessible for intratumoral injection must be present for treatment and assessment of response
	≥18 years of age
	Life expectancy of ≥6 months per the investigator
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	ECG without evidence of clinically significant arrhythmia or ischemia
	If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment or if receiving rituximab, 12 months after last treatment
	If male and sexually active with a FCBP, must agree to use effective contraception such as latex condom or is sterile (e.g., following a surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment or if receiving rituximab, 12 months after last treatment
	Exclusion Criteria
	Cancer therapies, including chemotherapy, radiation (non-study regimen related), biologics or kinase inhibitors, granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to the first scheduled G100 dose
	Investigational therapy within 4 weeks prior to G100 dosing
	Prior administration of G100 or other intratumoral immunotherapeutics
	Inadequate organ function including
	Marrow: Peripheral blood leukocyte count (WBC) <3000/mm3, absolute neutrophil count ≤1500/mm3, platelets <75000/mm3, or hemoglobin <10 gm/dL
	Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >2.5 × the upper limit of normal (ULN), total serum bilirubin >1.5 × ULN (patients with Gilbert's Disease may be included if their total bilirubin is 3.0 mg/dL)
	Renal: Creatinine >1.5 × ULN
	Other: international normalized ratio (INR) or partial thromboplastin time (PTT) >1.5 × ULN
	Significant immunosuppression from
	Concurrent, recent (≤4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
	Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or conditions such as common variable hypogamma¬globulinemia
	Pregnant or nursing
	Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
	History of other cancer within 2 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)
	Recent (<1 week ago) clinically significant infection, active tuberculosis or evidence of active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
	Central nervous system involvement with lymphoma, including parenchymal and leptomeningeal disease. In Parts 4 and 5, any involvement with lymphoma in a closed or confined space such as the retroorbital area will need to be pre-approved by the Medical Monitor
	Significant autoimmune disease, including active non-infectious pneumonitis, with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy. (Replacement therapy for hypothyroidism or diabetes is allowed.)
	Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent
	History of significant adverse or allergic reaction to any component of G100, and if enrolled in Part 4, pembrolizumab and/or any of its excipients, and if enrolled in Part 5, anti-CD20 antibodies including rituximab and/or any of its excipients
	Use of anti-coagulant agents or history a significant bleeding diathesis
	Has received a live vaccine within 30 days prior to the first dose of study drug (Applies to patients who may receive either pembrolizumab or rituximab). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed
	For patients enrolled in Part 4 with the potential to receive pembrolizumab
	Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or interstitial lung disease
	Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD].)
	Has had an allogeneic tissue/solid organ transplant
	Has received prior therapy with an anti-PD-1, anti-programmed death ligand (PD-L)1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials or was previously treated with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event

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Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma