NCT05037825: PARADIGM

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Recruiting now Last updated 27 April 2022

What this trial tests

trial testing Checkpoint Inhibitor, Immune in Non-Small-Cell Lung Carcinoma in 800 participants. Currently enrolling.

Timeline

22 November 2021

Primary endpoint
14 September 2023

14 September 2028

Quick facts

Lead sponsor	VastBiome
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	800
Start date	22 November 2021
Primary completion	14 September 2023
Estimated completion	14 September 2028
Sites	1 location across United States

Drugs / interventions tested

• Checkpoint Inhibitor, Immune — full drug profile →

Conditions studied

• Non-Small-Cell Lung Carcinoma — all drugs for Non-Small-Cell Lung Carcinoma →
• Malignant Melanoma — all drugs for Malignant Melanoma →
• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Triple-Negative Breast Cancer — all drugs for Triple-Negative Breast Cancer →

Sponsor

VastBiome — full company profile →

Who can join

18 and older, any sex, with Non-Small-Cell Lung Carcinoma or Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combination therapy with immune checkpoint inhibitors (ICIs); a new frontier.
   Vafaei S, Zekiy AO, Khanamir RA, Zaman BA, et al · · 2022 · cited 190× · PMID 34980128 · DOI 10.1186/s12935-021-02407-8
2. Role of gut microbiome in cancer immunotherapy: from predictive biomarker to therapeutic target.
   Zhang M, Liu J, Xia Q. · · 2023 · cited 77× · PMID 37770953 · DOI 10.1186/s40164-023-00442-x
3. Role of Gut Microbiota in Breast Cancer and Drug Resistance.
   Viswanathan S, Parida S, Lingipilli BT, Krishnan R, et al · · 2023 · cited 38× · PMID 36986390 · DOI 10.3390/pathogens12030468
4. The Role of the Gut Microbiome in Cancer Immunotherapy: Current Knowledge and Future Directions.
   Kiousi DE, Kouroutzidou AZ, Neanidis K, Karavanis E, et al · · 2023 · cited 29× · PMID 37046762 · DOI 10.3390/cancers15072101
5. Gut-lung axis: role of the gut microbiota in non-small cell lung cancer immunotherapy.
   Zhang H, Xu Z. · · 2023 · cited 20× · PMID 38074650 · DOI 10.3389/fonc.2023.1257515
6. Igniting Hope for Tumor Immunotherapy: Promoting the "Hot and Cold" Tumor Transition.
   Wei C, Ma Y, Wang F, Liao Y, et al · · 2022 · cited 19× · PMID 36147198 · DOI 10.1177/11795549221120708
7. From Bench to Bedside: How the Tumor Microenvironment Is Impacting the Future of Immunotherapy for Renal Cell Carcinoma.
   Anker J, Miller J, Taylor N, Kyprianou N, et al · · 2021 · cited 19× · PMID 34831452 · DOI 10.3390/cells10113231
8. Updates in combined approaches of radiotherapy and immune checkpoint inhibitors for the treatment of breast cancer.
   Jungles KM, Holcomb EA, Pearson AN, Jungles KR, et al · · 2022 · cited 18× · PMID 36387071 · DOI 10.3389/fonc.2022.1022542